Regulatory Affairs Manager: FDA Submissions & Compliance
Collabera
A leading IT staffing firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to ensure compliance with FDA and other regulations for medical devices. This role requires a minimum of 5 years in regulatory affairs, including experience with 510(k) submissions and interaction with FDA. The candidate should possess a Bachelor's degree in a scientific or engineering field and have a solid understanding of manufacturing and change control. This position offers the potential for permanent employment after an initial 6-month period. #J-18808-Ljbffr Collabera
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Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Suggested- Temp to Perm - Remote Opportunity - Regulatory Affairs Manager Established in 1991, Collabera has... ...Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.... ...lead the preparation, analysis, and submission of dossiers to various governing agencies...SuggestedRemote jobPermanent employmentTemporary workLocal area
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy for Orthopaedics products across... ...U.S. You will guide licensing, registrations, and submissions, interfacing with FDA and international agencies to ensure compliant launches...Suggested
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to support regulatory activities for marketed products and development programs. You will work across Medical, Commercial, Legal and Compliance to file and maintain applications in compliance with regulatory...
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...merit.Job Function: Regulatory Affairs GroupJob Sub Function... ...a Regulatory Affairs Manager. This position may be... ...marketing, and related submissions to support optimal... ...communications with FDA and international regulatory... ...personal and Company compliance with all Federal,...Full timeLocal areaImmediate start- Regulatory Affairs Manager / Regulatory Affairs Specialist role Established in 1991, Collabera has... ...Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.... ...lead the preparation, analysis, and submissions dossiers to various governing agencies...Permanent employmentLocal area
- Regulatory Affairs Program Manager (Medical Device Divestiture) Location: Raynham, MA /... ...regulatory registrations, submissions, and documentation from a... ...while ensuring regulatory compliance and seamless execution. Key... .... Expertise with FDA 510(k), PMA, global registrations...
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...a Sr. Director, Regulatory Law, located in Raynham... ...with Regulatory Affairs, Quality, R&D,... ...innovation, compliance, and sustainable... ...development, lifecycle management, and global... ...counsel on regulatory submissions, product clearances... ...and apply FDA, EU MDR/IVDR, and...Full timeImmediate start$224.9k - $404.6k
...Norwood MA site and will be responsible for managing a team of CMC experts that prepare and... ...related agency correspondence and regulatory applications. This position will be required... ...CMC regulatory strategies for submissions(e.g. IND/CTA/BLA/MAA) and identify regulatory...Permanent employmentFull timeWork at officeWork from home- Moderna is seeking aRegulatory CMC Senior Leader based in Norwood, MA to manage a team of CMC experts overseeing regulatory correspondence and submissions. You will steer product strategy across portfolio and drive regulatory activities for high-quality CMC sections. You...
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Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product... ...strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating... ...The candidate will need to successfully manage multiple projects in a fast and results-... ...effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify...Permanent employmentFull timeWork at officeWork from home$103.11k - $154.67k
...at Point32Health.Job SummaryThe Lead Compliance Program Manager will be responsible for development,... ...with established, revised, or new regulatory requirements that impact the organization... ...collection, review, and submission. Perform review of regulatory audits...Full timeWork at officeWork from homeFlexible hours$184k - $230k
...Summary The Director, Compliance leads the day-to-... ...Cosmetic Act and FDA advertising and... ...resolution, CMS submission, and... ...Medical, Legal, and Regulatory review committee;... ...organizational, and project‑management skills; able to... ...Quality, Medical Affairs, Commercial,...Contract workTemporary workFor contractorsFixed term contractWork at officeFlexible hours3 days per week- ...Products Inc. is looking for a Sr. Director, Regulatory Law to serve as the leading legal... ...will provide strategic counsel, ensuring compliance with regulatory standards and guiding... ...experience, you will advise on regulatory submissions, monitor changes in law, and...
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...and Thursday. POSITION OVERVIEW The Manager, Regulatory Affairs will play a key role in providing... ...Medical, Commercial, Legal and Compliance, and Technical Operations to file... ...IND) and New Drug Application (NDA) submissions to the FDA to support development programs and...Work at officeLocal area$178k - $307.05k
Sr. Director, Regulatory Law Locations: New Brunswick,... ...partner with Regulatory Affairs, Quality, R&D, and... ...to enable innovation, compliance, and sustainable growth... ...counsel on regulatory submissions, product clearances, approvals... ...to interpret FDA, EU MDR/IVDR, and other...Immediate start$178k - $307.05k
Sr. Director, Regulatory Law (DePuy Synthes) Location:... ...counsel on regulatory submissions, product clearances and... ...Partner with Regulatory Affairs and Quality leadership... ...interpret and apply FDA, EU MDR/IVDR, and other... ...to assess regulatory compliance or risk associated with...Immediate start$196k - $342.7k
...their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... ...be considered as a single submission.Purpose:DePuy Synthes, a... ...assessments to Platform management of the impact of new and changing... ...and practices are in compliance with appropriate regulatory...Full timeLocal areaImmediate start- ...Pharmaceuticals, Inc. is a US-based pharmaceutical company seeking a Director of Compliance to lead the enterprise compliance program under the GC/CO. You will own operational compliance with AKS, FCA, FDA rules, and privacy laws, partnering with Finance, Legal, and IT to...
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...The Regulatory Affairs (RA) Manager of Global Labeling Compliance leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving... ...from diverse global authorities (e.g., FDA, EU MDR) and environmental directives (e.g., WEEE,...Full timeTemporary workWork experience placementLocal areaImmediate startRemote workWorldwideFlexible hours$142.4k - $213.6k
Schneider Electric has an opportunity for a U.S. Customs & Trade Compliance Manager. This is a hybrid role (2 days in-office) to be based in... ...’s global trade compliance strategy in the region, ensuring regulatory adherence and risk mitigation. Roles & Responsibilities: You...Full timeTemporary workWork at officeFlexible hours$160k - $185k
...Associate Director of PV Compliance is responsible for... ...compliance and quality management program to ensure adherence... ...industry trends and regulatory changes, adjusting... ...documentation for regulatory submissions and Information.... ...Strong understanding of FDA, EMA, MHRA, and global...Temporary workLocal areaFlexible hours$142.5k - $256.5k
...Associate Director, Global Regulatory-CMC will coordinate regulatory... ...with stakeholders, and manage multiple projects to support... ...regulatory strategies for global submissions (IND, CTA, BLA, MAA) and... ...submission readiness, ensuring compliance with health authority guidelines...- ...& Johnson is seeking a Sr. Director, Regulatory Affairs for Joints, Digital and Power Tools. Based... ...regulatory strategy, lead global submissions, and partner with R&D and platform leaders... ...digital technologies, and ensure compliance across strategic markets with strong leadership...
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...motivated Director, Quality Compliance to lead the quality compliance... ...identifying and assessing regulatory and quality risks during site... .... This individual will manage continuous inspection readiness... ...experience in preparing regulatory submissions and response to health...- .... is seeking a Senior Director of Advertising & Promotion - Regulatory Affairs to lead regulatory reviews for prescription, OTC, and cosmetic... ..., primarily in the US with Canada support. The role ensures compliance with regulatory agencies and oversees promotional labeling...
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The Manager, Indirects & Capex Strategic Sourcing will lead procurement of non-manufacturing goods and services supporting... ..., and Facility Management to ensure business continuity, regulatory compliance (cGMP/FDA), and optimal total cost of ownership (TCO). The position...Contract work
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