Regulatory Affairs PM - Medical Devices Strategy

DEKA Research and Development; Manchester (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

DEKA Research and Development is seeking a Regulatory Affairs Project Manager to lead regulatory strategy for medical device programs. You will define requirements, prepare submissions, and guide cross‑functional teams to approvals and clearances.

You will interact with the FDA and international regulators, mentor staff, and continuously improve regulatory processes to shorten time to market while maintaining compliance.

Qualifications

• Bachelor of Science in a technical field.
• Minimum 5 years in medical device, drug or biologic regulatory roles with successful approvals/clearances.
• Experience with FDA interactions including PMAs, 510(k)s, IDEs and premarket submissions.
• Strong written and verbal communication skills.
• Ability to balance priorities in a fast-paced environment.

Responsibilities

• Define and execute regulatory requirements for product approvals and clearances.
• Lead preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers.
• Provide leadership to R&D on regulatory strategies across product lifecycles.
• Mentor regulatory staff and cross-functional partners on regulatory tactics.
• Lead FDA engagements and support clinical trial design and approvals.

Skills

Regulatory Strategy

FDA Interactions

Project Management

Clinical Trials

Regulatory Compliance

Cross-functional Leadership

MDR/Post-market

Education

BS in a technically related field

Tools

eSTAR

Job description

DEKA Research and Development is seeking a Regulatory Affairs Project Manager to lead regulatory strategy for medical device programs. You will define requirements, prepare submissions, and guide cross‑functional teams to approvals and clearances.

You will interact with the FDA and international regulators, mentor staff, and continuously improve regulatory processes to shorten time to market while maintaining compliance.