Regulatory Affairs Specialist - Permanent - East Coast US
Lead the way in regulatory strategy for innovative Class III implantable devices in a dynamic, global environment.
À±½·ÊÓƵ is seeking a Regulatory Affairs Specialist to join a dynamic team in the US. This remote-based role involves preparing, reviewing, and maintaining regulatory submissions while supporting product lifecycle management from development through post-market activities.
Primary Responsibilities:
The successful candidate will be focused on ensuring compliance with FDA regulations for high-risk and Class III implantable medical devices, including degradable and bioabsorbable implants. Collaboration with global teams and cross-functional stakeholders will be key to success in this position.
Skills & Requirements:
- Bachelor's degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or a related field.
- Experience preparing, reviewing, and submitting regulatory documentation, particularly for Class III medical devices.
- Strong understanding of US FDA regulatory pathways, including PMA and/or 510(k) processes.
- Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR).
- Proficiency in using regulatory information management systems or submission tools.
- Experience working with CROs or external partners for regulatory submissions.
- Adaptable, detail-oriented, and proactive, with strong organizational and communication skills.
- Ability to work independently in a remote setting while collaborating effectively with global teams.
The Regulatory Affairs Specialist's responsibilities will be:
- Prepare, review, and submit US regulatory documentation, including IDEs, PMAs, PMA Supplements, and 510(k) submissions.
- Evaluate and ensure the accuracy and completeness of technical and clinical documentation for US registrations.
- Collaborate with global regulatory colleagues to align submission strategies and documentation.
- Support discussions with CROs, external consultants, and FDA representatives in coordination with senior regulatory leaders.
- Review labeling, instructions for use (IFUs), and promotional materials for compliance with US regulations.
- Ensure adherence to FDA regulations, including 21 CFR 807, 812, and 814, as well as applicable guidance for PMA and 510(k) submissions.
- Participate in audits and FDA inspections as a subject matter expert in Regulatory Affairs.
- Monitor changes in US regulatory requirements and assess their impact on products and documentation.
- Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality procedures.
If you are having difficulty in applying or if you have any questions, please contact Nathan Berkley at n.berkley@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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