Vice President Regulatory Affairs Quality Assurance - Bridgewater, United States - EPM Scientific

Description

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.