Principal Regulatory Affairs & Quality – Medical Device

My client seeks a highly skilled and experienced Principal Regulatory Affairs and Quality Medical Device Professional. In this role, as a pivotal member of the team, you would lead Regulatory Strategy and Compliance for a diverse range of medical devices. Working closely with cross-functional teams to ensure products meet global regulatory standards, providing safe and effective solutions for healthcare providers and patients. If you are passionate about ensuring the safety and effectiveness of medical devices, this is the perfect opportunity to impact healthcare worldwide positively.

Position: The initial focus of this role will be to ensure that regulatory files are compliant for 510K, de Novo, and PMA submissions; identify gaps between 21 CFR Parts 800-1299 and EU MDR requirements, and ensure regulatory files are compliant with US regulatory requirements.

Responsibilities:

• Develop and execute US Regulatory Strategies for product development and submissions, ensuring alignment with global regulations and standards.
• Maintain compliance with relevant regulations, standards, and guidelines throughout the product lifecycle.
• Assist in preparing responses to US regulatory authorities’ questions within assigned timelines.
• Recommends changes for clinical protocol for US regulatory compliance.
• Recommends strategies for earliest possible approvals of clinical trials applications in US.
• Assist in preparing clinical trial site ethics review board/FDA applications for investigational device trial(s). Review interim or final reports for trial site ethics boards/FDA as required.
• Conduct risk assessments and collaborate with product development teams to mitigate potential regulatory risks.
• Ensure product labeling and packaging comply with US regulatory requirements.
• Act as a liaison between the Company and FDA, respond to inquiries and requests for information.
• Performs coordination and preparation of document packages for audits and inspections from all areas of the company, providing regulatory input to minimize the potential for findings of non-compliance.
• Provide guidance and training to cross-functional teams on regulatory requirements and updates to raise US requirements knowledge within the Company.
• Stay abreast of regulatory procedures and changes in regulations, standards, and industry trends to anticipate and adapt to evolving requirements.

Qualifications:

• Experience with 510(k) submissions and PMA applications required.
• Minimum of ten years of regulatory affairs experience in the medical device industry required.
• Bachelor’s degree in a relevant scientific or engineering field required (advanced degree preferred).
• Strong knowledge of FDA regulations (21 CFR 812, 814 and 820), ISO standards (ISO 13485: 2016, ISO 14971: 2019).
• Excellent knowledge of the applicable medical device regulations in various countries–including current developments (EU-MDR) is an advantage.
• Ability to work collaboratively in a cross-functional team environment.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Independent, reliable, and communicative personality for delivering high-quality.

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