Remote Regulatory Affairs Manager — FDA Submissions Leader
Collabera
- 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
$110k - $150k
...Tempus, we are building a regulatory team that will adopt... ...marketing authorization from FDA. Our Manager of Regulatory Affairs will work closely with our... ...and assisting with submissions and correspondence with global... ...develop testing plans #LI-remote$110,000-$150,000The...Remote workFull time- ...Johnson Innovative Medicine is seeking a Manager, Regulatory Medical Writing to support across key... ...-country postings and potential remote options. You will lead preparation of... ...and ensure regulatory compliance across submissions. Strong leadership, writing, and project...Remote work
$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
- ...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
- 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 job
- ...seeking an Executive Assistant to support our Chief Customer Officer and VP of Marketing in a fast-moving, remote role. This position requires meticulous calendar management, travel logistics, and cross-functional coordination across multiple time zones. You will handle...Remote job
- Nurix Therapeutics, located in Brisbane, CA, is seeking a Senior Manager, Regulatory Operations to join the Regulatory Affairs team. You will coordinate submissions in Veeva RIMS, compile documents for US FDA and global health authorities, and ensure regulatory compliance...
- 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
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to provide regulatory support for marketed products and development programs... ...include preparing INDs and NDAs, managing submissions to FDA and other health authorities, maintaining #J-18808-Ljbffr...
- ...of legal experience and will be expected to partner with leadership on crucial legal negotiations while designing scalable systems across the organization. The position offers a competitive salary and comprehensive benefits in a remote-first workplace. #J-18808-LjbffrRemote work
$177k - $278.08k
...Director, Global Regulatory Lead Oncology where... ...strategy and lead major submissions for high-impact... ...of a GRTPrimary FDA contact for... ...colleagues, line management, and key stakeholders... ...within regulatory affairs and implications across... ...'s Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workMinimum wageTemporary workLocal areaWorldwide$258.68k - $313.46k
...with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...will impact BMS, regulatory affairs or projects and provides... ...with the regulatory product managers (submissions) and regulatory operations... ...capability centers. Employees in remote-by-design or lab-based...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...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
- e2E is seeking an experienced Accounting Consultant to lead the firm's tax function for diverse clients in the Kansas City area. You will prepare and review returns for Corporations, Partnerships, and Individuals, while guiding a team and coordinating with outsourced resources...Remote jobLocal area
- ...pm est. Location: REMOTE EST Salary: MarketJob... .../Senior Director Regulatory AffairsDepartment:... ...AffairsLine Manager / Supervisor Job Title... ...Director of Regulatory Affairs will report to the... ..., review, and submission of regulatory... ...negotiations with FDA, EMA, MHRA and other...Remote work
$144.06k - $205.8k
...a key role in the regulatory affairs department. Responsible... ...for NMEs), with management oversight; driving submission related activities... ...company, and with the FDA and global health... ...in Northbrook, IL. Remote work from anywhere... ...minded life science leaders, all dedicated to improving...Remote workContract workWork at officeWork from homeWorldwide- ...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 job
- ...Biomarin Regulatory Affairs Manager USC or GC preferred REMOTE KEY RESPONSIBILITIES: The RNC Manager responsibilities may vary depending... ...that are contracted to perform regulatory submissions/HA interactions for global clinical trials....Remote work
$150k - $195k
...Associate Director, Medical Writing, responsible for leading regulatory submissions and ensuring high-quality documentation. Applicants should... ...requires collaboration with cross-functional teams and entails remote work with some onsite presence in San Diego. #J-18808-...Remote work- ...Description Overview Are you an experienced Regulatory Affairs Project Manager with business acumen and a keen eye... ...plan to assure new products meet submission, approval and commercial launch... ...support, learning on the job Hybrid/Remote workspace Benefits We believe our people...Remote workLocal area
$127k - $165k
Manager, Regulatory Affairs page is loaded## Manager, Regulatory Affairsremote type: Fully Remotelocations: Remote - US: San Francisco, CA: Orange County, CAtime type: Full timeposted... ...execution and talent development* Lead FDA submissions (510(k) or pre-submissions) with...Remote workFull timeWork at office$175k - $205k
...Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology company focused on discovering,... ...regulatory support through QC review of submission components, including CMC documents, labeling...Remote workTemporary workCasual workLocal areaWorldwideFlexible hours$113.41k - $141.76k
...medical technology leader for nearly 100 years... ...Responsible for managing support of regulatory affairs systems used to support... ...develop regulatory submissions, managing departmental... ...Interprets and applies FDA regulations to... ...% This is a fully remote position; however, occasional...Remote workWork at officeFlexible hours$97.5k - $136.5k
...About The Role The Manager I, Regulatory Affairs Operations will report to the Director... ...Vault RIM) and regulatory submissions activities. The Manager I,... ...and guidelines including FDA regulations, EMA guidelines... ...a hybrid work environment; remote work may be considered. We...Remote workWork at officeLocal area- ...Regulatory Affairs ManagerThe Regulatory Affairs Manager supports BioWave's current design and development activities... ...international registrations, including FDA 510(k) submissions and ex-U.S. market... ...Standard office environment and/or remote work.Physical Demands : The...Remote workWork at office
- Breakthru Beverage Missouri, LLC is seeking a Safety Manager to lead statewide safety initiatives, coordinate with local, state,... ...and regional groups, and advise senior operations and sales leaders on regulatory requirements. You will oversee Workers Compensation, incident...Remote jobLocal area
$100k - $140k
...Join to apply for the Regulatory Affairs Manager role at Keystone Industries We... ...setting, potential for 1 day remote. Ideal Candidates: Ideal candidates... ..., regarding product submissions, change notifications, and... ...Skills: Experience with the FDA 510K Submissions and EU MDR...Remote workWeekly payWork at officeFlexible hours
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!
- team lead data science Mansfield, MA
- team leader mental health Mansfield, MA
- quality control team lead Mansfield, MA
- merchandise team leader Mansfield, MA
- quality assurance team leader Mansfield, MA
- healthcare team leader Mansfield, MA
- team leader production Mansfield, MA
- team lead Mansfield, MA
- compliance team leader Mansfield, MA
- team supervisor Mansfield, MA


