DEKA Research & Development

3 months ago

Regulatory Affairs Project Manager

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Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Regulatory Affairs Project Manager responsible for formulating and executing regulatory strategies to obtain FDA approvals/clearances and international approvals (CE Marking) for medical device programs. Collaborates with customers and R&D to drive submissions (510(k), PMA, IDE, Technical Files) across product lifecycles, while leading FDA interactions and mentoring staff to improve regulatory processes and time-to-market.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
•Provide leadership and guidance to R&D and cross‑functional partners on regulatory strategies across the product life cycle
•Lead FDA interactions including in‑person meetings, teleconferences, and written submissions
•Participate in the design and conduct of clinical trials, and assist in obtaining regulatory approvals from the FDA, IRBs and ethics boards
•Continuously improve internal regulatory processes to increase efficiency and reduce time to market while maintaining compliance

Key Requirements

•BS in a technically related field
•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
•Strong written and verbal communication skills
•Experience with regulatory processes including eSTAR, UDI, product labeling, MDRs and Field Action Reporting; ISO 13485 and MDSAP knowledge

Experience:5+ yearsMedical devicesLife science

Education:Bachelor's

Skills:CommunicationLeadershipRegulatoryRegulatory strategy

Certifications:RAC

Languages:English

Tech Stack:ESTARUDIISO 13485MDSAP

Company Brief

DEKA Research & Development

DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor

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DEKA Research & Development

3 months ago

Regulatory Affairs Project Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
•Provide leadership and guidance to R&D and cross‑functional partners on regulatory strategies across the product life cycle
•Lead FDA interactions including in‑person meetings, teleconferences, and written submissions
•Participate in the design and conduct of clinical trials, and assist in obtaining regulatory approvals from the FDA, IRBs and ethics boards
•Continuously improve internal regulatory processes to increase efficiency and reduce time to market while maintaining compliance

Key Requirements

•BS in a technically related field
•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
•Strong written and verbal communication skills
•Experience with regulatory processes including eSTAR, UDI, product labeling, MDRs and Field Action Reporting; ISO 13485 and MDSAP knowledge

Experience:5+ yearsMedical devicesLife science

Education:Bachelor's

Skills:CommunicationLeadershipRegulatoryRegulatory strategy

Certifications:RAC

Languages:English

Tech Stack:ESTARUDIISO 13485MDSAP

Company Brief

DEKA Research & Development

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor