Remote Regulatory Affairs Manager — FDA Submissions Leader
Collabera
Mansfield, MA
- Remote job
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. Candidates need a Bachelor’s degree, 5+ years of experience in medical device regulatory affairs, and strong leadership skills. This position plays a critical role in supporting business growth and ensuring regulatory compliance. #J-18808-Ljbffr Collabera
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Remote Regulatory Affairs Manager — FDA Submissions Leader in Mansfield, MA vacancy
$135k - $150k
Jade Biosciences is hiring a Regulatory Affairs Manager to support regulatory strategies for their clinical-stage therapies. This remote position requires timely submissions and compliance with FDA regulations. Candidates should have extensive experience in regulatory...Remote job- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote job
$135k - $150k
Jade Biosciences is looking for a Regulatory Affairs Manager to support the execution of regulatory strategies in a remote position. Responsibilities include managing submissions and ensuring compliance with global regulations. The ideal candidate will have 5-8+ years...Remote job- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote job
- ...seeks a professional for regulatory oversight... ...including all US regulatory submissions and acting as the liaison with the FDA. A Bachelor's degree in... ...President of Regulatory Affairs. The ideal candidate should... ...role offers a hybrid or remote work environment with travel...Remote work
- Avance Clinical is seeking a Chief Commercial Officer (CCO) to lead market expansion and drive business development. You will be an integral part of the executive leadership team, reporting directly to the CEO, and responsible for crafting the commercial strategy in the...Remote work
Avance Clinical
New York, NY2 days ago - ...candidates will have senior compliance experience within regulated financial services, fintech, or related sectors, and the ability to engage with regulators and governance teams. This position is remote within the United States. #J-18808-Ljbffr Martin Executive RecruitingRemote job
- A startup accelerator is seeking an ambitious SaaS Co-Founder/CCO to lead the development of a startup. This 100% remote role offers funding options and access to a network of successful entrepreneurs. Key responsibilities include building a scalable startup and receiving...Remote job
- A healthcare firm is seeking a Head of Regulatory Affairs for a permanent, full-time position based in the United Kingdom. The role requires... ...candidate will deliver regulatory strategies, ensure compliance, and manage a high-performing team. Strong knowledge of ICH-GCP and...Remote jobPermanent employmentFull time
- BioSpace is seeking a Regulatory Writing Senior Manager in Washington D.C. to author and oversee regulatory submissions for product approvals. The candidate will lead writing activities and mentor junior writers while ensuring compliance with regulatory standards. Applicants...Remote job
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco,... ...drug approvals and submissions. Candidates should... ...in Regulatory Affairs CMC within the biotech... ...industry and be adept at managing complex global submissions... ...position is hybrid, with remote work and occasional...Remote job- Kite Pharma is looking for a Regulatory Affairs professional to join their San Francisco team. The ideal candidate will have over 7 years of... ...dental, and vision insurance. This role supports a flexible working policy with onsite and remote days. #J-18808-Ljbffr Kite PharmaRemote workFlexible hours
- A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities... ...US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a...Contract work
- Radiology Partners seeks a Regulatory Affairs Leader to drive FDA submissions, 510(k) planning, and De Novo strategies across medical devices and SaMD. You will manage the eQMS program, CAPA, and design history files, partnering with Engineering, Legal, and executives...Remote job
- 6AM City, LLC in New Jersey seeks an experienced Regulatory Affairs professional to prepare and review multiple regulatory submissions (ANDAs and NDAs) and respond to FDA queries. You will devise strategies, review meeting packages, and provide cross-functional regulatory...
- ...staffing firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to ensure compliance with FDA and other regulations for medical devices. This... ...affairs, including experience with 510(k) submissions and interaction with FDA. The candidate should possess...Permanent employment
- Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams. The ideal candidate holds...
- ...leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves... ...in the US and Europe. This is a remote position requiring expertise in compliance...Remote work
GForce Life Sciences
New York, NY2 days ago - ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...documents, and ensuring compliance with FDA regulations. Candidates should have a...Work at office
- ...compilation, and delivery of regulatory submission dossiers for... ...colleagues. Coordinate and manage Certificates of... ...chemistry, regulatory affairs or related discipline,... ..., particularly the US FDA. Preferred Qualifications... ...team collaboration and remote days for focused work,...Remote workWork at officeLocal area
NCBiotech
Durham, NC3 days ago - ...quality client experiences. The position will be instrumental in managing client relationships and ensuring compliance with US... ...service-minded approach. This position offers the flexibility of remote work within the United States or Canada. #J-18808-Ljbffr Avantia...Remote work
- Rise Technical Recruitment Limited is looking for a Senior Manager in Regulatory Affairs to lead regulatory strategy in Wilmington, Delaware. This role offers a unique opportunity to step into a Directorship, influence substantial projects, and enhance your career progression...Remote job
- Washington Department of Labor & Industries seeks a DOSH Compliance Manager for Region 4 (Tumwater, Kelso, or Vancouver) to lead a team of investigators and staff, ensuring occupational safety and health compliance across Southwest Washington. The role shapes policy, improves...Remote jobWork at office
- ...Access & Inclusion. This position is vital for overseeing financial management of grants to legal aid organizations, ensuring compliance, and... ...with at least one in a leadership role. The position allows four days of remote work weekly. #J-18808-Ljbffr State Bar of CaliforniaRemote jobWork at office
$177k - $278.08k
...Description Director, Global Regulatory Lead Oncology -... ...strategy and leading major submissions for high‑impact... ...member of a GRT. Primary FDA contact for projects... ...team colleagues, line management, and key stakeholders.... ...following Takeda’s Hybrid and Remote Work policy. #J-18808...Remote workTemporary workLocal area- ...seeking an Associate Director for Medical Writing to oversee regulatory submissions of critical documents related to life-changing therapies.... ...standards while mentoring junior writers. The position is mainly remote with a focus on collaboration across teams. #J-18808-Ljbffr...Remote work
$232k - $284k
...Director, US Regional Regulatory Lead About... ...of current US FDA guidance... ...the IND/NDA/BLA submission strategy to ensure... ...achieving regulatory affairs objectives.... ...opportunities May support managing workload... ...strategy leader skilled at working... ...Boston or 100% Remote, US East Coast...Remote workFull timeContract workTemporary workWork at officeFlexible hours$174.5k - $274.23k
Director, Global Regulatory Lead, GI & Inflammation... .... Is a leader both in the department... ...colleagues, line management, and key... ...Accountable for all US FDA submissions and approvals of... ...within regulatory affairs and implications... ...Takeda’s Hybrid and Remote Work policy. Takeda...Remote workMinimum wage16 hoursFull timeTemporary workLocal area$240.94k - $291.96k
...Position Director, US Regulatory Lead, GRS... ...primary focus on management of pulmonology asset... ...including upcoming NDA submission. The incumbent may... ...compliance with FDA commitments and timelines... ...in regulatory affairs (e.g. > 4-7 years)... ...), field-based/remote-by-design (travel...Remote workFull timeTemporary work$150k - $195k
...seeking an Associate Director, Medical Writing to oversee regulatory submissions. The candidate will manage medical writing projects, ensuring timely delivery of... ...skills are essential. This role allows for remote work but may require occasional travel. Competitive salary...Remote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Regulatory Affairs Manager — FDA Submissions Leader. Be the first to apply!
Related searches
- team lead data science Mansfield, MA
- quality assurance team leader Mansfield, MA
- leader Mansfield, MA
- helpdesk team lead Mansfield, MA
- disability team leader Mansfield, MA
- compliance team leader Mansfield, MA
- team coordinator Mansfield, MA
- team lead Mansfield, MA
- inventory team lead Mansfield, MA
- quality control team lead Mansfield, MA