DEKA Research & Development

2 days 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: 21 hours agoStatus: Live

Reposted: first listed 1 week ago

Job Summary

Own regulatory approval and clearance programs for medical device and life science products across the full lifecycle. Partner with customers and R&D teams to define regulatory requirements and lead preparation and submission of filings such as 510(k)s, PMAs, IDEs, and international dossiers. Serve as the point of contact for FDA interactions, support clinical trial planning, mentor regulatory staff and cross-functional partners, and improve regulatory processes to reduce time to market while staying compliant.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Define and execute regulatory approval and clearance programs, establishing regulatory requirements and leading preparation and submission of 510(k)s, PMAs, IDEs, and international dossiers.
•Provide leadership and guidance to R&D teams on regulatory strategies throughout the product life cycle.
•Mentor regulatory affairs staff and internal cross-functional partners on effective regulatory strategies and tactics.
•Lead FDA interactions, including meetings, teleconferences, and written submissions.
•Participate in the design and conduct of clinical trials and support obtaining and maintaining approvals from the FDA, IRBs, and/or Ethics Boards; continually improve internal regulatory processes to reduce time to market while maintaining compliance.

Key Requirements

•BS in a technically related field.
•Minimum 5 years of direct work experience in medical device, drug, or biologic regulatory roles with successful approvals/clearances.
•Experience in direct FDA interactions, including premarket notifications, IDEs, Q-submissions, and participation in face-to-face meetings.
•Strong written and verbal communication skills with ability to balance priorities in a fast-paced environment.
•Expertise in FDA processes and medical device quality regulations, including eSTAR, UDI, labeling, post-market reporting, MDRs, QMSRs, ISO 13485, and MDSAP.

Experience:5+ yearsMedical devicesLife sciencesDrugBiologicsFDA regulatory affairs

Education:

Skills:CommunicationPriority management

Certifications:RAC

Tech Stack:FDAESTAR510(k)PMAIDEUDIMDRISO 13485MDSAPQuality Management Systems Regulations (QMSRs)CE Marking

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

2 days 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: 21 hours agoStatus: Live

Reposted: first listed 1 week ago

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, establishing regulatory requirements and leading preparation and submission of 510(k)s, PMAs, IDEs, and international dossiers.
•Provide leadership and guidance to R&D teams on regulatory strategies throughout the product life cycle.
•Mentor regulatory affairs staff and internal cross-functional partners on effective regulatory strategies and tactics.
•Lead FDA interactions, including meetings, teleconferences, and written submissions.
•Participate in the design and conduct of clinical trials and support obtaining and maintaining approvals from the FDA, IRBs, and/or Ethics Boards; continually improve internal regulatory processes to reduce time to market while maintaining compliance.

Key Requirements

•BS in a technically related field.
•Minimum 5 years of direct work experience in medical device, drug, or biologic regulatory roles with successful approvals/clearances.
•Experience in direct FDA interactions, including premarket notifications, IDEs, Q-submissions, and participation in face-to-face meetings.
•Strong written and verbal communication skills with ability to balance priorities in a fast-paced environment.
•Expertise in FDA processes and medical device quality regulations, including eSTAR, UDI, labeling, post-market reporting, MDRs, QMSRs, ISO 13485, and MDSAP.

Experience:5+ yearsMedical devicesLife sciencesDrugBiologicsFDA regulatory affairs

Education:

Skills:CommunicationPriority management

Certifications:RAC

Tech Stack:FDAESTAR510(k)PMAIDEUDIMDRISO 13485MDSAPQuality Management Systems Regulations (QMSRs)CE Marking

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