Strategic Regulatory Lead — Medical Devices

DEKA Research & Development; Manchester (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical device company in Manchester, NH is seeking a Regulatory Affairs Project Manager. The role involves defining and executing regulatory strategies for FDA approval of innovative life science devices, mentoring staff, and leading FDA interactions. Candidates should have a BS in a related field and a minimum of 5 years' experience in medical device regulations. The position offers the opportunity to contribute to meaningful projects in an innovative and fast-paced environment.

Qualifications

• 5+ years in a medical device regulatory role with successful product approvals.
• Expertise in FDA processes and regulations, including eSTAR and QMSRs.
• RAC certification is a plus.

Responsibilities

• Define and execute regulatory approval and clearance programs.
• Lead FDA interactions and prepare regulatory submissions.
• Mentor staff on regulatory strategies and improve internal processes.

Skills

Regulatory Strategies

FDA Interactions

Clinical Trials

Communication Skills

Quality Management Systems

Regulatory Submissions

Education

BS in a technically related field

Job description

A leading medical device company in Manchester, NH is seeking a Regulatory Affairs Project Manager. The role involves defining and executing regulatory strategies for FDA approval of innovative life science devices, mentoring staff, and leading FDA interactions. Candidates should have a BS in a related field and a minimum of 5 years' experience in medical device regulations. The position offers the opportunity to contribute to meaningful projects in an innovative and fast-paced environment.