Regulatory Affairs Specialist II, Expansion Whoop IncRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
Regulatory Affairs Specialist II, Expansion WhoopRegulatory Affairs Specialist II, ExpansionBoston, MassachusettsThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.
Sr Regulatory Affairs Specialist Foundation Medicine IncSr Regulatory Affairs SpecialistBoston, MA$101,440–$126,800 / yearWrite, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to: Significant Risk Determination Requests (SRDs); IDE applications; Q-Submissions; Pre-market applications (PMAs, sPMAs); and, Performance Study Applications. Preferred Qualifications: Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting pre-sub, IDE application and/or PMA documents to FDA and other health authorities.
NewSenior Regulatory Affairs Specialist Meridian Bioscience IncSenior Regulatory Affairs SpecialistNorth Billerica, MA$101,600–$131,900 / yearResponsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates. Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistCambridge, MA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Sr. Specialist, Regulatory Affairs LeMaitreSr. Specialist, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Senior Regulatory Affairs Specialist - Software OrganOxSenior Regulatory Affairs Specialist - SoftwareBoston, MA$115,000–$140,000 / yearUnder direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
NewSenior Regulatory Affairs Specialist Hologic IncSenior Regulatory Affairs SpecialistCambridge, MA$40,000–$50,000 / yearTo deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.
Senior Regulatory Affairs Specialist - Clinical MinimedSenior Regulatory Affairs Specialist - ClinicalVirtual, MARemote$97,000–$165,000 / yearIf you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning IncContract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876)Tewksbury, MA$71,252–$97,972 / yearOur health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets.
Sr. Specialist, Regulatory Affairs LeMaitre Vascular IncSr. Specialist, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Sr. Regulatory Affairs Specialist Glaukos CorpSr. Regulatory Affairs SpecialistBurlington, MAOur constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Senior Regulatory Affairs Specialist - Clinical Medtronic MiniMed IncSenior Regulatory Affairs Specialist - ClinicalMARemote$97,000–$165,000 / yearIf you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.
Regulatory Affairs Specialist Medtronic PlcRegulatory Affairs SpecialistMansfield, MAIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Senior Regulatory Affairs Specialist Siemens HealthineersSenior Regulatory Affairs SpecialistWalpole, MARemoteFull timeIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Manager, Regulatory Affairs Program Canadian Nuclear Laboratories LtdManager, Regulatory Affairs ProgramBurlington, MAManaging the work of and leading technical specialists within the Branch, elsewhere within CNL, and external to CNL (as required) to ensure that requests for independent technical review of technical documentation submitted by Proponents, or requests by Proponents for independent review of activities at nuclear facilities at CNL sites, are accommodated and dispositioned effectively and efficiently with due regard to timely review while maintaining technical breadth and depth and not compromising safety. In consultation with the SRC Secretariat and Proponents, planning independent technical reviews, accepting hazard categories following the review of proposals by Proponents, liaising with the NCS Panel Chair and the NCS Panel Technical Secretary, chairing SRC independent technical review meetings, and ensuring that final review comments that are compiled from SRC technical reviewers are consistent and harmonized before they are sent to the Proponents.
Principal Specialist - Regulatory Affairs & Compliance Gorton'sPrincipal Specialist - Regulatory Affairs & ComplianceGloucester, MassachusettsMonitor and evaluate emerging regulatory trends, enforcement actions, recalls, and global food safety risks to proactively manage regulatory risks and ensure company strategies remain aligned with current and future compliance requirements. - Provide technical expertise to support Gorton’s businesses in all areas related to ingredients, labeling and claims, legal, governmental and regulatory issues, including FDA registration requirements.