Regulatory Affairs Project Manager at deka

Location: Manchester, New Hampshire
Type: Full-time
Posted: Jul 15, 2026

Description

DEKA Research & Development Corp. is seeking a Regulatory Affairs Project Manager to lead regulatory strategy execution for medical device R&D. The role involves defining and executing regulatory approval programs, preparing submissions like 510(k)s and PMAs, mentoring staff, managing FDA interactions, participating in clinical trial design, and improving internal regulatory processes.

Required Skills

Regulatory Strategies
FDA Approval
International Approvals
CE Marking
Establishing Regulatory Requirements
Preparation and Submission of Dossiers
Developing Successful Regulatory Strategies
Leading Preparation and Submission of Dossiers
FDA Interactions
Clinical Trials
Improve Internal Regulatory Processes
Highest Levels of Compliance
Written and Verbal Communication Skills
Balance Priorities in Dynamic Environment
FDA Processes Including eSTAR Tool
Medical Device Quality Regulations
Expanding Regulatory Organization Capabilities
Drug/Biologic Product Approvals
RAC Certification

Additional Information

Required Previous Experiences: Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and participation in face-to-face meetings
Preferred Qualifications: Experience with drug, biologic and combination product approvals a plus
RAC certification a plus