Senior Regulatory Affairs Specialist

About the role

This is a remote role. As a Senior Regulatory Affairs Specialist, you will be responsible to:

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
• Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams.
• Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS).
• Collaborate with cross‑functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance.
• Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy.
• Provide training to internal stakeholders on country‑specific regulatory requirements, as applicable.
• Independently or as part of a team, review promotional and labeling materials for regulatory compliance in accordance with country‑specific requirements.
• Ensure audit‑ and inspection‑ready documentation and provide guidance to cross‑functional teams on appropriate regulatory documentation practices.
• Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum of 4 years of experience in IVDs or medical devices.
• Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance.
• Knowledge of point-of-care IVD products and applicable regulations for such products.
• Experience of working in a GMP environment.
• Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps.
• Intercultural sensitivity.
• Strong attention to detail and excellent organizational skills.
• Excellent presentation skills, team orientation, and communication skills.
• Able to multi-task and work effectively in a dynamic environment.
• Nimble learning and ability to actively seek out relevant legislation and competitive information on product lines.
• Ensure cross-functional collaboration and cooperation.

Pay & benefits

• Base pay range: $117,770 – $161,931 (factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate).
• Benefits (subject to applicable eligibility requirements): medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.