Senior Principal Regulatory Affairs Specialist - Transfusion
About The Position
As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities associated with the manufacture and distribution of the Werfen product lines for U.S., Canada, and European Union. This role requires a thorough understanding of medical device and biologics regulations and standards, and involves preparing and maintaining regulatory documentation, reviewing changes for regulatory impact, coordinating field actions and vigilance activities, and ensuring compliance with listing requirements. The specialist will also assist with regulatory inspections and collaborate closely with various internal departments.
Requirements
- Bachelor’s degree in science, engineering or related field required.
- Minimum of eight (8) years of experience in the US, EU, and international regulatory affairs within the medical device industry required.
- Thorough knowledge of the product development and design control process.
- Sophisticated knowledge of and experience with FDA medical device and/or biologics regulations and guidance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 1348:2016 Quality System standards, ISO 14971:2019 Risk Management, and other applicable US and international regulations, guidances, and standards required.
- Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
- Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
Nice To Haves
- RAPS certification and membership, preferred
Responsibilities
- Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation)
- Prepares and maintains Technical Files (Technical Documentation)
- Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
- Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
- Maintain regulatory product files of information submitted in support of domestic and international registrations
- Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
- Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
- Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
- Maintains compliance with Medical Device Listing requirements for Werfen products
- Recognizes and elevates critical regulatory/compliance issues to RA management
- Assists with the administration of regulatory and third-party inspections.
- Performs other duties as assigned
Benefits
- Werfen is an Equal Opportunity employer and is committed to a diverse workplace.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
