QARA Director

Director of Regulatory Affairs

Company Overview:

Opportunity to join a Class II medical device company that is completely removing the invasiveness of cancer diagnosis procedures to improve patient experience. This will be a role for a seasoned Regulatory Affairs professional who enjoys navigating the complexites of global regulations

Key Responsibilities:

• Developing and implementing comprehensive regulatory strategies for Class II medical devices to ensure market access and compliance across key markets, including the US, EU, APAC, and LATAM.
• Serve as the primary contact for regulatory agencies during audits, inspections, and submission reviews.
• Ensure compliance with applicable regulations, standards (e.g., ISO 13485, MDR), and internal policies.
• Provide strategic regulatory advice to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Represent the company at industry forums, conferences, and regulatory meetings.

Qualifications:

• Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred).
• 8 years of experience in regulatory affairs, including leadership roles, in the medical device industry.
• Strong understanding of international medical device regulations (e.g., FDA 21 CFR 820, EU MDR, Health Canada, APAC, LATAM requirements).
• Ability to work onsite in Atlanta, where the product is manufactured.