Regulatory Affairs Project Manager

Job overview

The Regulatory Affairs Project Manager role is onsite in Manchester, NH. Compensation is not specified. The position supports DEKA Research & Development’s medical-device research and development work, contributing to innovative life-science devices. The role exists to formulate and execute regulatory strategies that secure FDA and international approvals or clearances. It contributes across the product life cycle by guiding regulatory submissions, agency interactions, clinical-trial approvals, and process improvements that support compliance and time to market.

What you'll do

• Define and execute regulatory approval and clearance programs with customers and development teams
• establish regulatory requirements and lead preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and international dossiers
• guide R&D regulatory strategies across the product life cycle
• mentor regulatory staff and cross-functional partners
• lead FDA interactions
• participate in clinical-trial design and conduct and support approvals from FDA, IRBs, and ethics boards
• improve regulatory processes and procedures.

What we're looking for

Skills & competencies

regulatory affairs project manager

manchester nh

deka research & development

medical devices

fda submissions

510(k)

pma

ide

ce marking

regulatory strategy

clinical trials

r&d

Work arrangement

• Weekend coverage required

Why this role

High-visibility regulatory leadership role spanning FDA submissions, international approvals, and medical-device product development.

About the employer

DEKA Research & Development is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.