Sr. Manager, Regulatory Affairs - Medical Devices - REMOTE

Location

New Brunswick, NJ | United States

Job description

Sr. Manager, Regulatory Affairs - Medical Devices - Permanent - Remote

Proclinical Staffing is seeking a Sr. Manager, Regulatory Affairs - Medical Devices to join a global mid-sized medical diagnostics and imaging company. This is a permanent role with the opportunity to work remotely.

Primary Responsibilities

In this role, you will be responsible for assisting in the management of medical device regulatory compliance to global regulations and required standards for the company's medical device products. You will be responsible for products distributed in the United States, Canada, Europe, South America, Asia Pacific, the Middle East and Africa.

Skills & Requirements:

• B.S. or B.A. degree in life sciences, engineering or chemistry curriculum.
• At least five years of experience in medical device regulatory affairs
• Experience with labeling, EU Technical Files and international registrations is required
• Must be eligible to work in the US.

The Senior Manager, Regulatory Affairs will:

• File amendments globally and update files as necessary and update documentation in the medical device registration files as necessary, including but not limited to:
• EU: updating Essential Requirements, Technical File Summary, Vendor and Component Information, Standards, Clinical Evaluation Documents,
• Australia: updating Essential Principles and generation and maintenance of the Manufacturer Declaration
• Canada: updating Canadian Compliance Checklists
• Japan: working with the MAH in Japan to update registrations as required
• Assemble documentation for new medical device regulatory filings
• Assemble and maintain 510(k) medical device submissions
• Assemble and maintain European Technical Files
• Assemble and maintain worldwide medical device product registrations
• Author Global Regulatory Assessments for product changes
• Labeling:
• Generate revised artwork in compliance with the regulations
• Maintain and update the RA Labeling Tracker for status of all open label files and follow-up as required
• Track label changes through the process
• Provide finished artwork to suppliers and obtain proofs

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected] .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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