Work-life balance appreciative medical device leader seeks a Manager Regulatory Affairs to lead Regulatory Affairs activities for electromechnical medical devices. This is for 510(k) experienced Regulatory Affairs professions looking for a place to call home.
Responsibilities for this Regulatory Affairs Manager include:
• Supervise and develop one or more Regulatory Affairs Specialists
• 510k Submissions for Active Medical Devices
• Regulatory Strategy input for US and Canadian submission plans
• FDA communications
• Product Registrations
• Risk analysis and product labeling regulatory review
• Regulatory assessments as related to developing regulations or product changes as well as to new products.
Requirements for this Regulatory Affairs Manager include:
• BS degree
• 510k submissions a requirement
• 6+ years US Regulatory Affairs experience in Medical Devices (Pharmaceutical exp. a plus too but Medical Device is required)
• Experience assessing product changes
• Leadership experience
• Software controlled / electromechanical / active Medical Device experience preferred
Diverse array of medical devices (especially active medical devices) and pharmaceutical product experience awaits you in the entry level Regulatory Affairs Manager opportunity. You will also be joining a team that can offer desired flexibility in your quest to grow professionally.
Location/Region: Allentown, PA (US)