Regulatory Affairs Specialist Jobs in the United States
Medline Industries - Transportation & Operations
Springfield, IL
Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Daiichi Sankyo, Inc.
Bernards, NJ
The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
Sanofi
Morristown, NJ
The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Leadership Background: Global Leadership experience with a mid-size/large Regulatory CMC organization, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning.
Takeda Pharmaceutical
Cambridge, MA
As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. See Takeda Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/ and Privacy Policy at https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions.
Takeda Pharmaceutical
Boston, MA
Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
Takeda Pharmaceutical
Boston, MA
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
BHE GT&S
$67100 - $111000 YEAR
Glen Allen, VA
Provides research, prepares analyses, and gathers supporting information that will be presented to senior management, regulators, customers, internal counsel, external counsel, and outside consultants. Bachelor (Typically four years of related, progressive work experience would be needed for candidates applying for this position who do not possess a bachelor's degree.).
Civica Rx
Petersburg, VA
CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Implement, track, trend, and analyze quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
Treehouse Foods
Green Bay, WI
This role will collaborate with internal technical and non-technical teams, as well as external partners, to manage documentation, provide regulatory guidance, and support site audits and continuous improvement efforts. We are investing in talent and creating a performance-based culture where employees can do their best work and develop their careers, directly impacting our mission to make high quality, affordable food for our customers, communities, and families.
Fast Pace Health
Midway, TN
Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.
Cardinal Health
$90600 - $109990 YEAR
Waukegan, Illinois
Job responsibilities include regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Specific activities include but are not limited to: Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.
Amneal Pharmaceuticals
Piscataway, NJ
Assists in organizing meetings with FDA or other Health Authorities, including submitting the meeting requests, setting up internal preparation meetings, assist meeting leads in preparing presentations and talking points, and type-up meeting minutes. Description: The Regulatory Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and other Health Authorities, as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws.
The Exeter Group
Chicago, IL
Provide leadership and direction related to clinical collaborative studies, programs, or research related initiatives that improve the lives of our patients as well as the communities in which they live. Ensure metrics for organizational and clinical outcomes are consistently reviewed, and that the organization is provided with clear guidance and direction on ongoing improvements in the quality of care.
Sanofi
Cambridge, MA
is Responsible for optimizing the early development operational strategy, implementation and realization of FIM to POC/POCC studies based on input from all applicable functions within the CSO, in order to create the most value for the project team and the platform for operational tasks . Collaborates upfront with CSCO, Demand and Supply Leader and CMC Leader in order to secure all aspects linked to IMP (e.g: in use study anticipation, pharmacy manual, IP delivery) .
Cardinal Health
$76700 - $88500 YEAR
Mansfield, Massachusetts
Job responsibilities include support of change development projects, new product development, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution.
Sanofi
Morristown, NJ
Enhance medical awareness among healthcare providers regarding significant medical discoveries and practice trends in Sanofi’s aT1D portfolio and pipeline through educational initiatives, including communicating the important outcomes data related to Sanofi products. Advanced degree (PhD, PharmD, MD, DO or equivalent) in a relevant scientific or medical field (e.g., endocrinology, immunology, pharmacy and medicine), or advanced practice provider (NP with MSN/DNP or Physician Assistant with master's degree) with endocrinology experience.
University of Pennsylvania
$62000 - $70119 YEAR
Philadelphia, PA
Qualifications: The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials.
Sunrise Systems Inc
$59 - $62 HOUR
Irvine, CA
Regulatory Affairs is responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval. Our client, a leading Medical Devices Manufacturing Company is looking for Regulatory Affairs - Specialist 3 and This is for an initial duration of 10 MonthsContract – Irvine, CA.
OQSIE
Swiftwater, PA
Contribute to the label control, format and design of packaging for leaflets, cartons and labels of specific products and coordinate implementation of labeling components in collaboration with Industrial Operations where appropriate. This position will contribute to the Quality Enhancement Plan (QEP) through continuous and vigilant evaluation of labelling compliance via the Labelling Change Control process and the end to end labeling process flow.
Activ8
$60000 - $70000 YEAR
AUSTIN, TX
We specialize in connecting top talent with companies in the Automotive, Electronics, Food & Beverage, Logistics, Manufacturing, Oil & Gas, Banking & Finance, and Entertainment industries. Our client-focused approach ensures that we understand your unique needs, whether you’re a company seeking skilled professionals or a candidate looking for the right career opportunity.
BaRupOn LLC
$60000 - $76000 Annually
Irvine, CA
This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of evolving federal and state regulations related to pharmaceuticals, medical devices, and controlled substances. The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements.
Schwan's Company
$48000 - $80000 YEAR
Hopkins, MN
The incumbent works under the guidance of project leaders to complete specifications, develop required labeling features and labeling documentation, proof graphics, obtain government approvals, for new products, product enhancement, and cost reduction products to meet project parameters and business unit strategies. + Documents various work according to established procedures and guidelines, provides timely and effective oral and written communication and prepares reports to project team to ensure complete communication of project status, progress, issues, solutions, timeline, and accountability.
Arthrex
Naples, FL
Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments to collect technical information and data associated with the preparation of international regulatory documents to support Arthrex subsidiaries and distributors new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests and international marketing bid/tenders. Research and respond to inquiries from Arthrex subsidiaries and distributors to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, international marketing bid/tenders and to support quality tasks related to foreign manufacturer registrations.
Biofire
$71000 - $105000 YEAR
Salt Lake City, UT
In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. Planning objectives and strategies to achieve them within a set timelineInforming others by sharing clear, timely information to ensure alignmentAbility to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.
A-Line Staffing Solutions LLC
$58.92 HOUR
Irvine, CA
The Regulatory Affairs Specialist III supports the planning, coordination, and execution of regulatory submissions for products requiring government approval. The ideal candidate is self-motivated, detail-oriented, and comfortable navigating complex documentation systems to locate and validate information.
Lumenis
San Jose, CA
This role leads cross-functional initiatives to achieve timely product approvals and market access, monitors regulatory changes, prepares & manages submissions, maintains compliance with applicable regulations & laws, liaison with regulatory agencies and supports continuous improvement across the regulatory function. Product Lifecycle Support: Collaborate and lead cross-functional regulatory projects with R&D, Marketing, Quality, and Manufacturing teams to ensure regulatory compliance during design control, risk analysis, verification & validation and release of documentation into documentation management system while managing timelines.
Integer Holdings Corporation
Palm Harbor, FL
You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. While you will have occasional support and guidance from more experienced regulatory professionals, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
Central Garden & Pet
Phoenix, AZ
Central is home to a leading portfolio of more than 65 high-quality brands including Amdro®, Aqueon®, Cadet®, C&S®, Farnam®, Ferry-Morse®, Four Paws®, Kaytee®, Nylabone® and Pennington®, strong manufacturing and distribution capabilities, and a passionate, entrepreneurial growth culture. For over 40 years, Central has proudly nurtured happy and healthy homes by bringing innovative and trusted solutions to its consumers and customers and has an exciting opportunity for a skilled and experienced FDA Regulatory Affairs Specialist to join our team!
Boehringer Ingelheim
$75000 - $147000 YEAR
Ridgefield, CT
Contributes to database maintenance activities for clinical trials to ensure information is current and correct (e.g., IND/IMPD Comparative Tables, GMP Tables outlining cGMP certificates and Manufacturing Authorizations/Permits). Facilitate Knowledge Sharing/Management: + Supports/maintains knowledge sharing systems within G CMC RA (e.g., REGWIKEPDIA, Knowledge page, US CMC RA Webpage, etc.
Hologic
Louisville, CO
Hologic’s Surgical division is seeking a Regulatory Affairs Specialist to drive global product commercialization, support New Product Development (NPD), and ensure continued market access for our cutting-edge surgical technologies. + Collaborate with cross-functional teams—including R&D, Clinical, Quality, and Marketing—participating in design reviews and developing regulatory strategies for product approvals.
Amazon
$114400 YEAR
Seattle, WA
Key job responsibilities - Drive Regulatory Strategy: Develop and coordinate site-specific strategies for obtaining government aviation approvals while facilitating conversations and agreements with aviation stakeholders at local and national levels - Prepare and Submit Required Applications and Assessments: Play a key role in drafting, obtaining approvals, and submitting multiple required applications and assessments to the FAA and other bodies - Support Site Selection and Roll-out: Review potential new Prime Air sites to identify airspace issues and local airspace users - Serve as Regulatory Expert: Act as the subject matter expert supporting internal teams, keeping stakeholders informed about regulatory developments - Lead Cross-Functional Collaboration: Partner with Legal, Public Policy, Public Relations, Engineering, and Operations teams to manage projects effectively and align on goals, approaches, and messaging This role requires travel, up to 30% of the time. You will ensure that Prime Air is fully engaged with other airspace users to guarantee safe use of airspace and will translate complex technical objectives into regulatory strategies while navigating the rapidly evolving landscape of unmanned aircraft systems regulations.
Mondo
$100000 - $130000 YEAR
Norcross, GA
Lead U.S. regulatory activities for pre-market submissions, ensuring full compliance with FDA requirements for IVD and medical device products. Location-Type: Hybrid Preferred (Norcross, GA) – Open to remote or relocation for highly qualified candidates.
Applied Medical
$70000 - $80000 YEAR
Rancho Santa Margarita, CA
Engage in regulatory strategy planning and change management for various markets, including Asia Pacific, Latin America, the European Union, and MENAT (Middle East North Africa). Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.
CEDENT
Addison, TX
Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications, etc. Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.
CEDENT
Boston, MA
Comfortable working directly for regulatory agencies, including the Food and Drug Administration (FDA), DEA, and Boards of Pharmacies. The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance, requirements, submissions, and overall regulatory affairs activities.
Axelon Services Corporation
Valhalla, NY
The primary focus of this position is to support graphic refreshes of the Beverages portfolio which includes the development of the nutrition and ingredient label declarations that are compliant with US FDA regulations, as well as support updates to legacy label information documentation. The position will require a basic understanding and application of US Food and Drug Administration labeling regulations to ensure the accuracy and regulatory compliance of ingredient statements, nutrition facts, allergen declarations, and claims.
Integer Holdings Corporation
$113025 - $165770 YEAR
Plymouth, MN
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. 2. Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
Stryker
Redmond, WA
Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. + Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.
Meta
Burlingame, CA
Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level.
Hologic
Marlborough, MA
You’ll collaborate with talented cross-functional teams to drive product launches, implement changes, and support international registrations, all while maintaining precise and up-to-date regulatory documentation. As a Regulatory Affairs Specialist supporting our dynamic Surgical division at Hologic, you’ll play a vital role in bringing life-changing medical devices to market—both in the U.S. and around the world.
Amazon
$133800 YEAR
Seattle, WA
In this position you will serve as a bridge between Amazon's innovative technology teams and regulatory bodies, engaging with internal experts to determine and update Prime Air's regulatory goals and translating those objectives into regulatory strategies while navigating the evolving landscape of unmanned aircraft systems regulations. You'll be instrumental in obtaining setting and achieving regulatory goals, engaging with regulators and other decision makers, and helping to establish the framework that will further enable safe, scalable drone delivery operations across the United States.
CEDENT
Boston, MA
Audit Support: Supporting external regulatory agency audits by providing necessary documentation and regulatory input to minimize potential findings of non-compliance. This role encompasses a variety of study types, including observational and interventional studies, across all clinical trial phases from Phase 1 to Phase 4. What We’re Looking For.
Market America Inc
Greensboro, NC
This position provides scientific and regulatory support to Product Management, Marketing, and international partners to ensure products and related materials comply with applicable regulations and are supported by credible science. Note: This is a non-laboratory position focused on regulatory research, literature evaluation, and product support — not hands-on experimental or academic research.
Unilever
$70000 - $77000 YEAR
Seattle, WA
We offer space to thrive-personally, professionally, and through our comprehensive benefits package designed to support your well-being at every stage: + Generous paid time off, including time off to volunteer + Learning and development resources to support personal and professional growth + Wellness benefits like meditation app memberships, product discounts, and free samples of our amazing products + Most roles are fully remote (roles that are required to be at our Seattle HQ can be found in the details section of this job post) + Great location - for roles that are hybrid or fully onsite, we're in the heart of Seattle's beautiful International District? **Where Trust Leads, Bold Ideas Grow, and Community Thrives** Paula's Choice, a global skincare leader founded in 1995, empowers individuals to define beauty on their own terms through science-backed products.
Trinite Consulting Group
Rosemont, IL
Partner with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to compile required information and ensure compliance for all new products, changes to existing products, and post-market activities related to drug-device combination products. The Regulatory Affairs Specialist/Senior Specialist for Drug-Device Combination Products will serve as an essential resource within the organization, providing technical expertise and regulatory guidance for the development, manufacturing, and commercialization of drug-device combination products.
CEDENT
Plano, TX
The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies.
Eliassen Group
$110000 - $140000 YEAR
Marlborough, Massachusetts
The role supports two IDE programs, accelerates global submissions, strengthens Notified Body interactions, and provides an onsite regulatory presence in a fast-paced, multi-project environment. Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group.
Enterra Medical, Inc.
St Louis Park, MN
A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and/or in vitro diagnostic medical devices. Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.
Novanta
Sarasota, FL
We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing. The specialist ensures adherence to design control and change management processes, supports audits and customer interactions, and manages safety-related complaints in collaboration with Medical Affairs.
Jack Link's Protein Snacks
$85000 - $100000 undefined
Minneapolis, Minnesota
The company’s portfolio of brands includes Jack Link’s®, Lorissa’s Kitchen®, Wild River®, Golden Island®, Country Fresh Meats®, BiFi®, Peperami® , Mariani and Local Legends Meat Snacks. Headquartered in Minong, Wisconsin, Jack Link’s is strategically positioned with production, distribution, and support centers in key locations throughout North America, Brazil, Europe, and the Pacific Rim.