Vice President Regulatory Affairs Quality Assurance

3 weeks ago


Trenton, United States EPM Scientific Full time

Responsibilities: Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements. Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA. Provide guidance and expertise on regulatory requirements, standards, and best practices related to PMA submissions. Collaborate with cross-functional teams to gather and compile necessary data and documentation for PMA submissions. Ensure compliance with regulatory requirements and standards throughout the PMA process, from pre-submission to post-approval activities. Manage interactions with regulatory agencies and represent the company in PMA-related meetings and communications. Establish and maintain a robust quality management system (QMS) to support PMA submissions and ongoing compliance. Lead quality assurance initiatives to maintain high standards of product quality and safety throughout the PMA process. Provide leadership, mentorship, and development opportunities for the regulatory affairs and quality assurance teams. Qualifications: Bachelors degree in a scientific or engineering discipline; advanced degree preferred. Minimum of 12 years of experience in regulatory affairs and quality assurance within the medical device industry. Proven track record of successful PMA submissions and approvals for medical devices. Thorough understanding of FDA regulations, guidance documents, and PMA requirements. Strong leadership skills with the ability to drive results and foster a culture of compliance and quality. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Strategic thinker with the ability to develop innovative regulatory strategies and solutions.

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