Regulatory Affairs Specialist
$74,400–$111,600 year
On-siteBoston, Massachusetts, United States or North Haven, Connecticut, United States
Job Summary
Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy for surgical access technologies. Provide regulatory input to product development, lifecycle planning, and change control activities, while assessing the regulatory impact of proposed design, labeling, manufacturing, and process changes. Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings. Support audits, inspections, and regulatory authority interactions as needed, and participate in risk management activities to ensure regulatory considerations are addressed appropriately. Monitor tracking systems for regulatory deliverables and collaborate with internal stakeholders to resolve issues and keep activities on track. Stay current on applicable regulations, standards, and guidance documents relevant to assigned products and markets.
Required Qualifications
- Bachelor's degree
- Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)
Desired Qualifications
- Experience with U.S. FDA and international regulatory requirements for medical devices
- Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
- Experience supporting regulatory submissions, audits, or inspections
- Strong written and verbal communication skills
- Strong organizational skills with the ability to manage multiple priorities
- Experience collaborating in a cross-functional, fast-paced environment
- Familiarity with medical device product development or lifecycle management
- RAC certification or progress toward certification
- Experience working with Notified Bodies or global regulatory agencies
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