Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist that will lead and perform regulatory submission/approval activities for the company’s medical device products as directed with primary responsibility for FDA. This individual will provide clinical study regulatory support, some international (outside North America) regulatory submission support, coordinate with FDA and international regulators on submission reviews and approvals and ensure compliance with required regulations and established corporate standards.  

At Anteris® Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Main Responsibilities:

• Define regulatory requirements necessary for regulatory approval of products in North America. Complete North American regulatory assessments as required to support projects and provide direction to project teams to support new product development and product modifications as required.
• Provide direction on application of external standards for all projects as required. Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for North America.
• Lead regulatory activities for product field corrective actions to maintain compliance and ensure that product approvals are properly maintained, and product re-submissions are properly managed.
• Assist in the development and implementation of required post-market surveillance.
• Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for international markets.
• Coordinates timely renewal of certificates, licenses, and registrations.
• Assist in creation of product labeling and instructions for use [package inserts] by collaborating with cross-functional business partners.
• Review and approve marketing literature and other items for compliance with relevant regulatory requirements.
• Assist in the development and implementation of the Physician Payments Sunshine Act.
• Author, review, and/or approve internal operating procedures related to regulatory affairs.
• Knowledge of Quality Systems Manual, Product Development, QSR & MDD, Complaint Handling.

Skills, Knowledge, Experience & Qualifications

• A bachelor's degree in a science or engineering concentration is required.
• Minimum of 5 years of experience in Regulatory Affairs
• Requires 5+ years' medical device industry experience including authoring PMA, IDE, and 510(k) submissions, preferably in the cardiovascular field. 
• Experience with Class III devices required.
• Experience with Health Canada and international market submissions a plus
• Strong working knowledge and experience with quality systems regulations and guidelines, ISO 13485, GMP, Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR) and FDA regulatory requirements.
• Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
• Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions.
• RAC Certification preferred.
• Microsoft Office software experience.
• Leadership: Foster teamwork, lead courageously, champion change.
• Motivation: Drive for results, work commitment.
• Self-Management: possess integrity, exhibit honesty, demonstrate adaptability.
• Interpersonal: value diversity, develop relationships.
• Communication: communicate openly, listen to others.
• Thinking: demonstrate sound judgment, assess strategically, analyze issues.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options for full-time employees.
• Career development opportunities and a chance to be part of a growing company that values its employees.