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Featured Companies are employers who have come directly to FlexJobs, been approved by our staff, and have directly posted their jobs to the FlexJobs site.
- Hybrid Remote Work
- Full-Time
- Employee
- 133,500 - 253,500 USD Annually
- North Chicago, IL
Develop and implement US and Canada regulatory strategic planning for assigned products. Manage interface with FDA for key projects/issues, advise internal customers on regulatory/FDA issues, and coordinate preparation of FDA meeting briefing package..
- 100% Remote Work
- Full-Time
- Employee
- US National
The Associate Manager, Regulatory Affairs Operations is responsible for supporting the development of regulatory submissions, managing eDMS workflows, ensuring adherence to regulatory requirements, and acting as a liaison with external organizations ..
- Hybrid Remote Work
- Full-Time
- Employee
- Sparks, MD, Franklin Lakes, NJ
Assess and develop regulatory pathways for new products, plan submissions to regulatory agencies, represent company in interactions with agencies, monitor and implement regulatory requirements, design and implement regulatory training.
- Hybrid Remote Work
- Full-Time
- Employee
- 100,000 - 120,000 USD Annually
- Mount Pleasant, WI
Ensure compliance for food, beverage, pet food, nutraceuticals, and biotechnology. Monitor and communicate regulations. Engage with industry associations. Provide timely responses to inquiries. Maintain regulatory information systems.
- 100% Remote Work
- Full-Time
- Employee
- Waltham, MA
Ensuring regulatory compliance for pharmaceutical products, preparing and submitting regulatory filings, conducting regulatory intelligence, maintaining awareness of regulations and guidelines, and recommending process improvements.
- Full-Time
- Employee
- Dublin, Ireland
Manage global regulatory affairs requirements, prepare and project manage device registrations for approval by the US FDA and EU Competent Authorities, liaise with regulatory authorities, and contribute to the development of the Regulatory Strategy.
- 100% Remote Work
- Full-Time
- Employee
- NY, IL, MI, MN, PA, TX, VA, WA
Manage regulatory affairs teams, ensure compliance with laws and regulations, shape legislative policies through lobbying efforts, develop and implement regulatory strategies, build relationships with government agencies, mentor team members, partici..
- Hybrid Remote Work
- Full-Time
- Employee
- North Chicago, IL
Develop and implement regulatory strategies for US and Canada, including HA liaison, submission preparation, and approval process. Support cross-functional teams, recommend changes, and operate in compliance with regulations and corporate policies.
- Hybrid Remote Work
- Full-Time
- Employee
- Irvine, CA
Coordinate, compile, and submit regulatory documents, ensure compliance with international regulations, evaluate product modifications, and provide regulatory guidance. Requires Bachelor's degree and 4-6 years of regulatory product registration exper..
- 100% Remote Work
- Full-Time
- Employee
- 88,800 - 133,200 USD Annually
- Boulder, CO, or US National
Planning and executing global regulatory activities for obtaining and maintaining regulatory approvals. Reviewing design, manufacturing, and specification changes. Maintaining proficiency in worldwide regulatory requirements and establishing good rel..
- 100% Remote Work
- Full-Time
- Employee
- 273,400 - 410,000 USD Annually
- Washington, DC
Set Legal vision, mission, and strategy for Regulatory Affairs. Collaborate with internal clients and Legal Department colleagues globally. Provide strategic legal counsel on drug and medical device development legal and regulatory issues.
- 100% Remote Work
- Full-Time
- Employee
- San Diego, CA, Atlanta, GA, TX, NJ, IL, NC, AZ
Represent international regulatory affairs and provide guidance on regulatory requirements. Lead regulatory efforts to comply with new regulations. Review protocols and reports for global regulatory submissions. Improve work processes and execute the..
- 100% Remote Work
- Full-Time
- Employee
- WA, OH
Provides administrative support to the department, including management and maintenance of regulatory documents, tools, and websites. Assists in the revision and maintenance of department webpage. Assists with archiving of documents and submissions.
- Hybrid Remote Work
- Full-Time
- Employee
- San Francisco, CA
Develop and influence regulatory policy, obtain and expand regulatory approval for medical device portfolio, set strategy for regulatory approval, prepare regulatory submissions, interact with regulatory agency authorities, review and approve device ..
- Hybrid Remote Work
- Full-Time
- Employee
- 114,400 - 171,600 USD Annually
- Boston, MA, North Haven, CT
Provide strategic input on regulatory requirements for new technologies and product modifications. Prepare regulatory submissions for new products and changes. Participate in negotiations with regulatory authorities. Support international product...
- 100% Remote Work
- Full-Time
- Employee
- Charlotte, NC, or US National
Develop and execute regulatory strategies for medical devices. Manage regulatory assessments and submissions. Provide regulatory guidance and support to cross-functional teams. Stay current with regulatory requirements and updates.
- Hybrid Remote Work
- Full-Time
- Employee
- 88,000 - 124,000 USD Annually
- Irvine, CA
Represent regulatory function on manufacturing and product development teams, provide input on requirements, review/approve documentation, prepare/oversee packages for submission to agencies, monitor global regulations and propose suggestions for exp..
- Hybrid Remote Work
- Full-Time
- Employee
- 88,000 - 124,000 USD Annually
- Irvine, CA
Completing and maintaining regulatory approvals and clearances, creating complex regulatory submissions, providing guidance on regulatory requirements, and offering feedback on registration requirements for new and renewal registrations.
- 100% Remote Work
- Full-Time
- Employee
- TX
Responsible for providing guidance to assure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. Oversee ad/promo reviews to ensure regulatory compliance and support New...
- 100% Remote Work
- Full-Time
- Employee
- Lehi, UT, Petersburg, VA
Lead the regulatory affairs team in the development, submission, and FDA approval of Civica's medication portfolio. Assess regulatory success and provide leadership in product review and withdrawal. Compile and publish documentation for FDA submissio..
- Hybrid Remote Work
- Full-Time
- Employee
- Bridgewater, NJ
Provide support and needed information to all global regions on products across the company and subsidiaries product portfolio utilizing external manufacturing organizations EMO so that regions can file products with the needed documentation and inform...
- 100% Remote Work
- Full-Time
- Employee
- 165,000 - 200,000 USD Annually
- Needham, MA
Develop and implement global regulatory and compliance strategy for remote patient monitoring platforms and pharma partnerships. Support sales and business development with regulatory guidance. Lead product submissions and ensure compliance with regu..
- 100% Remote Work
- Full-Time
- Employee
- 180,000 - 225,000 USD Annually
- US National
Responsible for preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption applications.
- 100% Remote Work
- Full-Time
- Employee
- 124,800 - 181,700 USD Annually
- US National
Develop global regulatory strategies, prepare submissions, and guide project teams through successful dossier reviews with regulatory agencies. Collaborate with cross-functional partners to address non-conformances, anticipate regulatory obstacles, a..
- 100% Remote Work
- Full-Time
- Employee
- 215,000 - 296,000 USD Annually
- Hayward, CA, Brisbane, CA, or US National
Lead regulatory strategy for product development, mentor team members, interact with regulatory agencies, manage submissions, and provide training. Regulatory affairs experience required.
- Hybrid Remote Work
- Full-Time
- Employee
- Irvine, CA
Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners. Includes the preparation of key market international documents, including...
- 100% Remote Work
- Full-Time
- Employee
- 98,000 - 210,100 USD Annually
- WA, OR, CA, NV
Lead business unit in developing processes for new regulatory requirements. Partner with marketing, engineering, clinical, and quality teams. Provide strategic direction to streamline department processes. Serve as regulatory affairs representative t..
- Hybrid Remote Work
- Full-Time
- Employee
- 117,500 - 223,500 USD Annually
- Waltham, MA
Develop and implement regulatory strategies for assigned products in US and Canada. Liaise with FDA and advise internal customers on regulatory issues. Prepare and review regulatory submissions and operate in compliance with regulations and company p..
- Hybrid Remote Work
- Full-Time
- Employee
- 174,200 - 287,400 USD Annually
- Milpitas, CA, San Diego, CA
Responsible for global regulatory strategy and coordination of complex regulatory submissions. Serves as primary regulatory liaison and leads meetings with regulators. Contributes to the development of strategic and operational plans.
- Hybrid Remote Work
- Alternative Schedule
- Employee
- 324,800 - 401,200 USD Annually
- Brisbane, CA, Novato, CA, Somerville, MA, Woburn, MA
Lead the Regulatory CMC function, develop and implement global CMC regulatory strategies, oversee submission and approval process, ensure regulatory conformance, and collaborate with internal and external partners.
- Hybrid Remote Work
- Full-Time
- Employee
- Brisbane, CA, Novato, CA, Woburn, MA
Manage regulatory submissions for clinical and commercial products, coordinate project activities with Regulatory Operations, collaborate with project teams to implement regulatory strategies, draft responses to Health Agency questions, and evaluate ...
- 100% Remote Work
- Full-Time
- Employee
- 68,800 - 114,700 USD Annually
- NY
A Regulatory Affairs Specialist is sought to support regulatory submissions, develop product labeling, and contribute to the development of regulatory strategies. The ideal candidate will have strong client and financial acumen and be detail-oriented.
- 100% Remote Work
- Full-Time
- Employee
- 88,800 - 133,200 USD Annually
- Boulder, CO
Plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. Review design changes, manufacturing changes, and specification changes. Maintain proficiency in worldwide regula..
- Hybrid Remote Work
- Full-Time
- Employee
- Sofia, Bulgaria
We are looking for candidates with SDS Authoring or related experience within the sciences sector, including regulatory affairs, chemical compliance, and product stewardship or related fields. This is an ideal opportunity for someone who is looking..
- 100% Remote Work
- Alternative Schedule
- Employee
- 130,000 - 193,000 USD Annually
- Omaha, NE
Develop food safety and quality programs, support adoption of policies and procedures, engage and empower team in continuous improvement, gather and study data, participate in cross-functional teams, understand and execute against budget.
- 100% Remote Work
- Alternative Schedule
- Employee
- 130,000 - 193,000 USD Annually
- US National
Develop food safety and quality programs, support adoption of policies and procedures, empower team in continuous improvement, use analytics for process improvement, participate in cross-functional teams, understand and execute budget.
- 100% Remote Work
- Full-Time
- Employee
- 94,420.00 - 145,770.00 USD Hourly
- US National
Manage regulatory relationships, monitor emergency/state commission activities, develop complaint management programs, advance organization positions, and monitor legislative/regulatory activity. Bachelor's degree and 5 years' experience required. Sa..
- Hybrid Remote Work
- Full-Time
- Employee
- 117,000 - 150,000 USD Annually
- Boulder, CO
Oversee worldwide submission activities, maintenance of approvals and global regulatory strategies, author regulatory documents, provide guidance and recommendations, support highly technical product lines, and establish strong working relationships ..
- Hybrid Remote Work
- Full-Time
- Employee
- Covington, GA
Executes activities for collecting, verifying, approving, and maintaining the integrity of data attributes within PIM and RIM. Collaborates with multiple stakeholders across the businesses to collect data attributes.
- 100% Remote Work
- Full-Time
- Employee
- 50,000 - 55,000 USD Annually
- Naperville, IL
Support internal and external stakeholders by providing responsive communication and resolving student inquiries. Analyze student finance trends and present findings to management. Assist with team performance and identify areas for improvement and a..
- Hybrid Remote Work
- Full-Time
- Employee
- 97,000 - 178,000 USD Annually
- Plymouth, MN, San Diego, CA
Advise stakeholders on regulatory laws and regulations, develop global regulatory strategies, achieve device clearances/approvals, mentor other regulatory personnel, support process improvement initiatives, and collaborate with colleagues worldwide.
- Hybrid Remote Work
- Full-Time
- Employee
- 104,000 - 178,000 USD Annually
- Orlando, FL
Leading global regulatory affairs project teams for new product introductions and changes, ensuring compliant strategies and building external stakeholder relationships for safe and effective market entry.
- Hybrid Remote Work
- Full-Time
- Employee
- 95,000 USD Annually
- Cuyahoga Falls, OH
Assist in maintaining regulatory compliance and quality management systems. Develop and implement regulatory strategies for new products. Provide guidance on documentation and testing requirements. Support external audits and promote continuous impro..
- 100% Remote Work
- Full-Time
- Employee
- 220,000 - 235,000 USD Annually
- US National
Lead and contribute to global regulatory strategies, manage submissions, and collaborate with cross-functional teams. Provide hands-on leadership, communicate project updates, and maintain knowledge of global regulatory requirements.
- Hybrid Remote Work
- Full-Time
- Employee
- Cary, IL
Assess and author regulatory submissions for product marketing applications. Provide regulatory guidance to other departments. Review technical documentation prior to FDA submission. Communicate with regulatory agencies regarding submissions and foll..
- 100% Remote Work
- Full-Time
- Employee
- 190,000 - 190,000 USD Annually
- Washington, DC, New York, NY
Strategically engage civil rights organizations and other stakeholders to drive and manage relationships, build networks, and inform federal and state policy priorities and advocacy. Requires experience in technology-related policy and multi-stakehol..
- Hybrid Remote Work
- Full-Time
- Employee
- 60,600.00 - 96,800.00 USD Hourly
- San Francisco, CA
Collect, validate, and interpret financial reports data to ensure quality and accuracy. Apply understanding of report instructions, policies, and accounting concepts to review and process financial data. Perform hands-on exploratory data analysis usi..
- Hybrid Remote Work
- Full-Time
- Employee
- 43,919 - 52,661 USD Annually
- Philadelphia, PA
Assist with regulatory needs and ensure compliance of clinical trials and research studies with regulations and guidelines. Prepare and process approvals, track essential documents, and maintain regulatory files. Administrative duties and other respo..
- Hybrid Remote Work
- Full-Time
- Employee
- 98,200 - 131,000 USD Annually
- Woodland Hills, CA
Manage, hire, train, and mentor the regulatory affairs team. Coach and develop Regulatory Specialist team. Ensure compliance with domestic and international regulations. Drive international expansion initiatives and manage product information files.
- 100% Remote Work
- Full-Time
- Employee
- 130,000 - 140,000 USD Annually
- US National
Oversee product quality, compliance, and regulatory affairs. Develop and implement quality assurance policies, conduct audits, and ensure product formulations and labeling comply with regulations. Manage third-party regulatory partner and coordinate ..
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