Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote)

Senior Regulatory Affairs Specialist supporting post-market compliance for in vitro diagnostic products in US and international markets. Responsibilities include adverse event assessment, recall coordination, regulatory reporting, and development of compliance procedures.

Responsibilities

• Conduct timely assessments of adverse events and field actions to determine regulatory reportability
• Support MDR and recall decision-making; coordinate regulatory reporting activities across teams
• Develop regulatory justifications, documentation, and strategies for domestic and international submissions
• Represent regulatory affairs function on cross-functional project teams and interact with regulatory agencies
• Develop and implement procedures, work instructions, and best practices for post-market compliance

Requirements

• Minimum 5 years regulatory affairs experience with Bachelor's degree, or equivalent combination
• In vitro diagnostics company experience preferred; pharmaceutical, biologics, or medical device acceptable
• Strong FDA regulations knowledge; EU, Canada, Australia, Japan, China requirements preferred
• Ability to work independently with complex technologies and produce professional documentation
• Strong written and verbal communication skills
• Proficiency with office automation and corporate database tools

Compensation: $90,000 - $135,000 base