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Regulatory Affairs Manager Jobs in the United States

Regulatory Affairs Manager

Abbott Laboratories

$97300 - $194700 undefined

Abbott Park, IL

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Today
Regulatory Affairs Manager – Structural Heart (on-site)

Abbott Laboratories

$112000 - $224000 undefined

Santa Clara, CA

This individual will support project teams to obtain worldwide regulatory approval or clearance for division products as well as provide regulatory support to ensure compliance with all FDA/CE and international regulatory requirements. 3 years’ RA experience, including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 years in an RA project management role.

Today
Regulatory Affairs Manager – Heart Failure (on-site)

Abbott Laboratories

$112000 - $224000 undefined

Pleasanton, CA

As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Today
Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

Abbott Laboratories

$112000 - $224000 undefined

Alameda, CA

You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.

Today
Regulatory Affairs Coordinator (on-site)

Abbott Laboratories

$24.4 - $48.8 undefined

Sylmar, CA

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Today
Regulatory Affairs Project Manager – Vascular (on-site)

Abbott Laboratories

$97300 - $194700 undefined

St. Paul, MN

Minimum 3 years related regulatory affairs experience including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 year in an RA project management role. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

Today
Senior Manager Regulatory Affairs – Heart Failure (on-site)

Abbott Laboratories

$111300 - $222700 undefined

Atlanta, GA

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Today
Senior Regulatory Affairs Specialist

Abbott Laboratories

$75300 - $150700 undefined

Lake Forest, IL

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

Today
Senior Regulatory Affairs Specialist (on-site)

Abbott Laboratories

$75300 - $150700 undefined

Plymouth, MN

Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.

Today
Senior Regulatory Affairs Specialist – Cardiac Rhythm Management (on-site)

Abbott Laboratories

$86700 - $173300 undefined

Sylmar, CA

Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Today
Senior Regulatory Affairs Specialist – Cardiac Rhythm Management (on-site)

Abbott Laboratories

$86700 - $173300 undefined

Sylmar, CA

Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Today
Sr Regulatory Affairs Manager

FISI - FUJIFILM Irvine Scientific

Santa Ana, CA

Manager, Regulatory Affairs will be responsible for ensuring that product, process, and procedures are sufficiently controlled to assure the quality of products and compliance in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD D 98/79/EC, IVDR 2017/746, and Canadian Medical Device Regulation. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies.

1 day ago
Clinical Affairs Specialist/ Medical Writer

FISI - FUJIFILM Irvine Scientific

Santa Ana, CA

Assist in the development and preparation of the Clinical Evaluation Plan and Clinical Evaluation Reports (CERs) per MDR 2017/745 and MEDDEV2.7.1 to meet essential requirements in support of submission for CE mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance (class IIb and III products). The Clinical Affairs Specialist will be responsible for assisting in the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), conducting clinical literature searches, performing analysis of clinical literature, and evaluating and reviewing clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices.

1 day ago
Pharma R&D Regulatory Affairs Manager

Deloitte

Los Angeles, CA

QualificationsRequired:6+ years experience with relevant consulting experience.4+ years of Life Sciences industry experience in the Pharmaceutical R&D regulatory affairs function to include:Experience introducing new technologies such as GenAI/AI/ML and automation for pharmaceutical regulatory content or regulatory intelligenceUnderstanding of pharmaceutical regulatory data and regulatory filing requirementsExperience with pharmaceutical regulatory operating model transformationsExperience with regulatory digital transformations / innovationsExperience with submissions management, labeling, CMC change control and/or LCM processesKnowledge around generating pharmaceutical submissions packagesExperience with Veeva RIM and/or QMS implementations1+ years experience leading, managing and delivering complex engagements with resources in multiple locationsBachelor’s DegreeAbility to travel up to 50% on average, based on the work you do and the clients and industries/sectors you serveLimited immigration sponsorship may be availablePreferred:Ability to orchestrate, lead, and influence virtual teams, ensuring successful implementation of customer projectsPresentation skills with a high degree of comfort with both large and small audiencesDemonstrated experience driving both the sales cycle by taking the lead in framing out client opportunities and leading the pursuit team to create the proposal content for client discussionsStrong problem solving and troubleshooting skills with the ability to exercise mature judgmentDemonstrated experience with management and delivery of multiple strategic engagements for large global organizationInformation for applicants with a need for accommodation: The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. We help accelerate action and create connections that empower a digitally enabled, equitable future of healthAs a Manager you will lead and deliver small engagements, or components of large, complex engagements that identify, design and implement creative business and technology solutions for our clients.

1 day ago
Director, Regulatory Affairs CMC

Dyne Therapeutics

Waltham, MA

Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.

27 days ago
Director, Regulatory Affairs

Dyne Therapeutics

Waltham, MA

Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

27 days ago
Executive Director, EU Regulatory Affairs

Dyne Therapeutics

Waltham, MA

Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents. The Executive Director, EU Regulatory Affairs is responsible for the planning, management, support and execution of regulatory activities for Dyne product candidates covering Europe/UK/Switzerland by partnering with Global Regulatory Affairs program leads and other key functional stakeholders.

20 days ago
Associate Director, CMC Biologics

Dyne Therapeutics

Waltham, MA

Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. The Associate Director CMC, Biologics is responsible for supporting our internal CMC capabilities (antibody, new fusion proteins process & development) and for the management of external new fusion protein CDMO under cGMP.

13 days ago