Regulatory Affairs Specialist

Heraeus Group•Fridley, MN

4d•Hybrid

About The Position

The Regulatory Affairs Specialists are responsible for initiating global regulatory strategies for new products and post-market changes. They review post-market changes for devices currently marketed to determine regulatory impact and prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance. We are hiring two positions and these are based at the Fridley, MN location and Telecommuting permitted 4 days per week.

Requirements

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry and 5 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer
Alternatively, Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry and 2 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer
The five years of experience with a Bachelor’s degree or the two years of experience with a Master's degree must consist of experience with US and International medical device regulatory submissions, working with PMA or 510(k) devices, FDA, EU MDR, Health Canada, MHRA, MHLW, and TGA requirements, interactions with regulatory body/agency, and Vigilance/Adverse Event Medical Device Reporting.

Responsibilities

Initiate global regulatory strategies for new products and post-market changes.
Review post-market changes for devices currently marketed to determine regulatory impact.
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance.
Prepare and/or review technical documentation for Health Canada and submit regulatory recertifications and change notifications as appropriate.
Prepare and/or review appropriate documentation for initial submissions, change notifications, or renewals for EU MDR CE marked devices.
Keep up to date with changing regulations and educate cross functional peers on new medical device regulations, such as EU MDR or relevant guidance published by the FDA, etc.
Review international submissions to be submitted by our medical device company customers/partners.
Review and approve changes to currently marketed devices to determine impact to regulatory clearances / approvals.
Answer customer questions and provide letters/other documentation as is appropriate.
Support Notified Body and other regulatory agency audits.
Review and approve the rationale for reporting complaints to regulatory agencies and/or customers.
Ensure understanding of all quality policy/system items that are applicable.
Review and/or approve customer agreements for regulatory language that is relevant to the services provided.
Ensure that the information provided through the FURLS registration system with the FDA and the MDALL database in Health Canada is up-to-date and accurate regarding establishments licensing, owner/operator and medical device listings.
Update GUDID and/or EUDAMED database as needed for new and existing products.