Job Description

We are looking for a talented Senior or Principal Regulatory Affairs Specialist to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory strategy and managing submissions for new product launches for our client's cardiovascular medical device portfolio.

This hands-on role 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.

Qualifications of the Senior or Principal Regulatory Affairs Specialist:

• Bachelor’s degree in a scientific, engineering, or related field. An advanced degree or certification in Regulatory Affairs (e.g., RAC) is a plus.
• Minimum of 5 years of regulatory affairs experience in the medical device industry, focusing 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.
• 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 developing life-saving technologies.

Responsibilities of the Senior or Principal Regulatory Affairs Specialist:

• 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 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.
• Train and mentor junior regulatory staff, fostering a culture of compliance and continuous improvement.
• Manage regulatory projects, timelines, and deliverables to ensure timely product launches.
• Collaborate with external consultants and partners as needed to support regulatory activities.

Occupational Category: 11-9199.01 Regulatory Affairs Managers

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