Remote Principal Regulatory Affairs Specialist
2 weeks ago
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist. In this role, you will support the development and implementation of long-range regulatory strategies that impact the introduction of new products and the compliance of existing ones. Your leadership will guide regulatory staff, ensuring all products meet U.S. and international standards. You will be a key player in compliance activities and bear significant responsibility in product development and modifications. Accountabilities Maintain current knowledge of applicable laws and regulations. Interpret regulatory requirements for products and ensure compliance. Participate as a regulatory representative on project teams. Lead submission activities for device clearances/approvals. Review change orders and assess regulatory impact. Oversee labeling, training, and promotional material compliance. Represent the organization in working groups related to regulatory objectives. Support due diligence and post-acquisition assessments. Develop and implement regulatory education and training. Assist in policy and procedure development within the department. Requirements Bachelor’s Degree with 7+ years in regulatory affairs or relevant field. Medical device experience is required. Experience with 510(k) or PMA submissions for FDA. Knowledge of U.S. and EU regulations for medical devices. Excellent communication and presentation skills. Ability to manage multiple projects with attention to detail. Proficiency in MS Word, Excel, and PowerPoint. Benefits Competitive salary and flexible benefits package. Health, Dental, and Vision insurance. 401(k) plan with employer match. Paid time off and holidays. Tuition assistance and reimbursement. Employee Stock Purchase Plan. Short-term disability and life insurance. Employee Assistance Program. #J-18808-Ljbffr
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Principal Regulatory Affairs Leader
6 days ago
California, United States Medium Full timeA leading healthcare company is searching for a Principal Regulatory Affairs Specialist to oversee regulatory strategies and ensure compliance for healthcare products. This remote role involves mentoring junior staff and guiding regulatory submissions while maintaining knowledge of laws and standards. Candidates should hold a Bachelor's Degree and possess...
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Principal Regulatory Affairs Leader
5 days ago
California, United States Medium Full timeA leading healthcare company is searching for a Principal Regulatory Affairs Specialist to oversee regulatory strategies and ensure compliance for healthcare products. This remote role involves mentoring junior staff and guiding regulatory submissions while maintaining knowledge of laws and standards. Candidates should hold a Bachelor's Degree and possess...
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Senior Regulatory Affairs Specialist
2 weeks ago
California, United States Connect Life Science Full timeA leading MedTech company is looking for a Senior Regulatory Affairs Specialist. This role is primarily remote, with occasional travel, and offers a competitive pay range of $80-$100 per hour. The ideal candidate must have over 5 years of experience in Regulatory Affairs, particularly with Class III Medical Devices. Responsibilities include supporting FDA...
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Senior Regulatory Affairs Specialist
3 weeks ago
California, United States Connect Life Science Full timeA leading MedTech company is looking for a Senior Regulatory Affairs Specialist. This role is primarily remote, with occasional travel, and offers a competitive pay range of $80-$100 per hour. The ideal candidate must have over 5 years of experience in Regulatory Affairs, particularly with Class III Medical Devices. Responsibilities include supporting FDA...
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Senior Regulatory Affairs Specialist
2 weeks ago
California, United States Sinclair Pharma plc Full timeJob Details: Senior Regulatory Affairs Specialist Full details of the job. Vacancy Name: Senior Regulatory Affairs Specialist Vacancy No: VN462 Employment Type: Full-Time Location: Remote - California Sinclair is currently recruiting for a Senior Regulatory Specialist for the USA. The Senior Regulatory Specialist is responsible for regulatory activities...
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Senior Regulatory Affairs Specialist
24 hours ago
California, United States Sinclair Pharma plc Full timeJob Details: Senior Regulatory Affairs SpecialistFull details of the job.Vacancy Name: Senior Regulatory Affairs SpecialistVacancy No: VN462Employment Type: Full-TimeLocation: Remote - CaliforniaSinclair is currently recruiting for a Senior Regulatory Specialist for the USA. The Senior Regulatory Specialist is responsible for regulatory activities supporting...
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Senior Regulatory Affairs Specialist
2 weeks ago
California, United States Connect Life Science Full timeThis range is provided by Connect Life Science. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $80.00/hr - $100.00/hr Quality, Regulatory & R&D Staffing Expert | Contract & Permanent Hires | Building World Class Life Sciences Teams. We’re partnering with a scaling Class III MedTech...
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Senior Regulatory Affairs Specialist
21 hours ago
California, United States Connect Life Science Full timeThis range is provided by Connect Life Science. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $80.00/hr - $100.00/hr Quality, Regulatory & R&D Staffing Expert | Contract & Permanent Hires | Building World Class Life Sciences Teams. We’re partnering with a scaling Class III MedTech...
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Senior Regulatory Affairs Lead
2 weeks ago
California, United States Jobgether Full timeA regulatory consulting firm is seeking a Principal Regulatory Affairs Specialist to support the development and implementation of regulatory strategies for medical devices. This role involves ensuring compliance with U.S. and international regulations, leading submission activities, and maintaining knowledge of applicable laws. The ideal candidate has a...
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Senior Regulatory Affairs Specialist
2 weeks ago
California, United States Bayside Solutions Full timeSenior Regulatory Affairs Specialist Base pay range: $61.00/hr - $71.00/hr Salary Range: $129,000 - $147,000 per year Duties and Responsibilities Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical Files, international submissions). Maintain existing regulatory approvals, clearances, and documentation. Manage...
