Senior Manager Regulatory Affairs Medical Device

My client is seeking a highly motivated Regulatory Affairs professional to join their growing organization. In this role, you will be responsible for supporting global regulatory submissions and ongoing regulatory compliance through the product development lifecycle. This is the perfect opportunity for a regulatory professional who is looking to take the next step in their career.

Responsibilities:

• Independently prepare global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510Ks, IDEs, and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other international markets.
• Participate in compliance activities, such as internal audits, FDA and Notified Body audits, complaint handling, and vendor audits.
• Assist in preparing or updating documentation and labeling as required. 
• Assist in coordinating regulatory documentation such as device listings, certificates to foreign governments, and Canadian medical device licensing.
• Prepare materials for Management Review Meetings.
• Prepare and maintain the regulatory product classifications and groupings for new products within the context of the Medical Device Directive.
• Embed with Design/Development teams to provide both technical and RA input with a view to ensuring that design documentation resultant from the design-development process can be utilized for 510(k) and Technical Files with minimal (to no) modification.
• Write technically compelling essays to submit to FDA to prove substantial equivalency

Requirements:

• BS/BA, preferably in engineering or life sciences.
• 5+ years of experience with US and EU regulatory preparations and submissions.
• Experience in Class II electro-mechanical medical devices.
• Hands-on knowledge in preparing and submitting Clinical Evaluation Reports, Medical Device Regulation submissions, 510K preparations and submittals, ongoing reporting to Medical Device regulatory agencies and knowledge of other international regulatory requirements.
• Excellent organizational, technical writing, and communication skills.
• Proficiency with Microsoft Office.
• Knowledge of ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR.
• Experience drafting 510(k) documentation and EU Technical Documentation.

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