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
- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development...SuggestedRemote work
- Collegium Pharmaceutical, Inc. is seeking a Manager of Regulatory Affairs to lead regulatory support for... ...with Medical, Commercial, Legal, Compliance, and Technical Operations to file and... ...regulations. The position focuses on IND/NDA submissions, regulatory publishing, and labeling...Suggested
$224.9k - $404.6k
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- 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
- 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
- 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...
- 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 ManagerWe are searching for the best talent... ...a Regulatory Affairs Manager. This position may be... ..., and related submissions to support optimal timelines... ...communications with FDA and international regulatory... ...personal and Company compliance with all Federal,...Local 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...
$178k - $307.05k
...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$132.22k - $158.4k
...Manager, Regulatory Affairs Stoughton, MA Collegium Pharmaceutical is building a leading,... ...including Medical, Commercial, Legal and Compliance, and Technical Operations to file... ...) and New Drug Application (NDA) submissions to the FDA to support development programs...Work at officeLocal area$224.9k - $404.6k
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...- 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...
$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$142.5k - $256.5k
The Role:The 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$132.22k - $158.4k
...portfolio of responsible pain management and neuropsychiatry... ...POSITION OVERVIEW The Manager, Regulatory Affairs will play a key role in... ..., Commercial, Legal and Compliance, and Technical Operations... ...Drug Application (NDA) submissions to the FDA to support development...For contractorsWork at officeLocal area$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$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...
- ...cost. Job Description The Regulatory Affairs Operations (RA Ops) submission group is organized to... ...She/he also ensures that compliance standards are met for receipt... ...submissions through the FDA Gateway Ensure adherence... ...(sCubed and/or eCTD Manager), Validation Tools and...Immediate start
$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- ...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...
$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- ...& 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...
$90k - $210k
...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...$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...- .... 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...
- ...compliant, compelling content. The ideal candidate has 10+ years in pharmaceutical communications, strong writing and editing skills, and a track record mentoring writers while guiding cross-functional teams through complex regulatory review. #J-18808-Ljbffr Skill Corp
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Manager: FDA Submissions & Compliance. Be the first to apply!
- regulatory Mansfield, MA
- regulatory engineer Mansfield, MA
- regulatory compliance Mansfield, MA
- compliance technician Mansfield, MA
- compliance lead Mansfield, MA
- compliance team leader Mansfield, MA
- regulatory affairs Mansfield, MA
- regulatory affairs assistant Mansfield, MA
- compliance Mansfield, MA
- customs compliance Mansfield, MA


