Associate Manager – Regulatory Affairs

Associate Manager – Regulatory Affairs

Requirements

• Bachelor’s degree required. Preferred degree in a science, engineering, or related field.
• 6+ years of regulatory experience.

Responsibilities

• Lead teams to support regulatory processes for market access of products
• Manage budget, if appropriate
• May lead the development of new systems and procedures
• Plans, conduct, and supervise assignments
• Reviews progress and evaluate results
• Support continuous improvement activities
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
• Recruit and onboard top talent, develop team capabilities, proactively manage performance, and foster high team engagement
• Participates in advocacy activities of a technical audit/nature

Preferred Qualifications

• Master’s Degree or RAC preferred
• Previous supervisory experience preferred
• Experience with Class III Premarket Approval devices is highly desirable
• Familiarity with European medical device regulations
• Regulatory Affairs experience within Medical Device preferred
• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements
• Demonstrate technical knowledge of medical devices, tissues, and/or drug product lines
• Strong communication, team building, and leadership skills
• Proven ability to lead cross-functional teams, manage multiple projects, and drive process improvements
• Experience mentoring interns, interviewing candidates, recruiting, and coaching and developing team members preferred
• Understanding of scientific and health concepts