A growing medical device company based in North San Diego county is hiring a Regulatory Affairs Manager for their QA/RA department. The company is developing breakthrough products for the treatment of cardiac arrhythmias and will be commercializing several new products by the end of this year and early next.
The RA Manager will be responsible for leading the regulatory strategy and managing submissions for new product launches. This is a hands-on role that requires a deep understanding of regulatory requirements and processes, particularly in premarket submissions. The ideal candidate will have a blend of hands-on regulatory experience and some management capabilities to guide the team and ensure successful product approvals.
Responsibilities:
• Develop and implement regulatory strategies for new product development and commercialization.
• Prepare, review, and submit regulatory documentation to relevant regulatory bodies (e.g., FDA, EMA) to obtain necessary approvals for new products.
• Ensure compliance with all applicable regulatory requirements and standards throughout the product lifecycle.
• Coordinate and manage regulatory submissions, including premarket notifications (510(k)), premarket approvals (PMA), and CE marking.
• Liaise with regulatory authorities and respond to inquiries to facilitate the approval process.
• Provide regulatory guidance to cross-functional teams, including R&D, Quality, Marketing, and Clinical, to ensure alignment with regulatory requirements.
• Monitor and interpret regulatory requirements and changes, ensuring the company’s products and processes comply with current regulations.
• Develop and maintain regulatory files and documentation, ensuring accuracy and completeness.
• Participate in risk management activities and provide regulatory input for risk assessments.
Qualifications:
• Bachelor’s degree and a minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on premarket submissions.
• Proven track record of successful regulatory submissions and product approvals.
• Strong knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
• Hands-on experience with regulatory submissions, including 510(k), PMA, and CE marking.
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Experience with electronic submission systems (e.g., eCTD) is preferred.
