Our client, a pioneering medical device company, is seeking a dedicated Regulatory Affairs Manager to join their team and spearhead the regulatory strategy for new product launches.

This pivotal role involves managing regulatory submissions and ensuring compliance with requirements. The ideal candidate will have extensive experience in regulatory processes, particularly premarket submissions, and possess leadership qualities to guide their team towards successful product approvals.

KEY RESPONSIBILITIES

• Develop and execute regulatory strategies for product development and commercialization.
• Prepare, review, and submit regulatory documentation to relevant authorities (e.g., FDA, EMA) to secure necessary approvals for new products.
• Ensure adherence to all applicable regulatory requirements and standards throughout the product lifecycle.
• Manage regulatory submissions, including premarket notifications (510(k)), premarket approvals (PMA), and CE marking.
• Communicate with regulatory authorities and address inquiries to expedite the approval process.
• Provide regulatory guidance to cross-functional teams, including R&D, Quality, Marketing, and Clinical, ensuring compliance with regulatory requirements.
• Stay informed of regulatory requirements and changes, ensuring products and processes meet current regulations.
• Maintain regulatory files and documentation, ensuring their accuracy and completeness.
• Participate in risk management activities and offer regulatory input for risk assessments.
• Train and mentor junior regulatory staff, promoting a culture of compliance and continuous improvement.
• Oversee regulatory projects, timelines, and deliverables to ensure timely product launches.
• Collaborate with external consultants and partners as needed to support regulatory activities.

QUALIFICATIONS

• Bachelor's degree in a scientific, engineering, or related field; an advanced degree or certification in Regulatory Affairs (e.g., RAC) is advantageous.
• At least 5 years of regulatory affairs experience in the medical device industry, with a focus on premarket submissions.
• Proven success in regulatory submissions and product approvals.
• Strong understanding 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.
• Detail-oriented with strong analytical and problem-solving skills.
• Experience with electronic submission systems (e.g., eCTD) is preferred.
• Some management experience with the ability to mentor and guide junior staff.
• Passion for working in the medical device industry and contributing to the development of life-saving technologies.

The position comes with competitive salary, comprehensive health benefits, 401k match, annual bonus and more!