Director Molecular Regulatory Affairs, North America

Company Overview:

Diasorin is a global leader in diagnostic solutions, providing innovative products and services to healthcare providers across the world. Our Immuno and Molecular Diagnostics teams focus on delivering state-of-the-art diagnostic technologies and solutions that improve patient outcomes. As we continue to expand our presence in North America, we are seeking a Director of Molecular Regulatory Affairs, North America to support the Molecular RA team and RA VP NA in identified the regulatory strategy, ensuring our products meet all regulatory requirements in the region while supporting our ambitious growth in the Immuno and Molecular Diagnostics markets.

Position Overview:

The Director of Molecular Regulatory Affairs, North America, will be responsible for supporting all regulatory functions and activities related to Molecular Diagnostics products across North America. This leadership role will ensure full support in identifying regulatory strategies to be aligned with company goals and the evolving regulatory environment in the healthcare industry. The Director Molecular RA, NA will also collaborate with key cross-functional teams including R&D, Legal, Marketing, Clinical Affairs, and Operations to assure RA Compliance in submission process for North American market, including the United States and Canada.

Key Responsibilities:

1. Cross Functional cooperation on Key projects:
• Support RA team in developing and implementing regulatory strategies for the Molecular Diagnostics portfolio in North America, ensuring timely market access for all new products and continued compliance for existing products.
• Support the team, fostering a high-performance culture and a deep understanding of regulatory requirements and industry standards.
• Identifying potential risks and opportunities and ensuring alignment with global corporate objectives.
• Stay abreast of industry trends and regulatory changes impacting product approval processes, quality standards, and market access requirements in the U.S. and Canada.

1. Regulatory Compliance and Approvals:
• In conjunction with RA team assure Compliance in submissions and approvals for new Molecular Diagnostics products with the FDA, Health Canada, and other relevant regulatory bodies.
• Review regulatory filings, including preSubmissions, 510(k) premarket notifications, PMA (Premarket Approval) applications, and other relevant filings as required by regulatory authorities.
• Partner with RA team in the preparation and submission of regulatory documents, ensuring that all submissions meet regulatory requirements and are completed on time.
• Establish and maintain relationships with key regulatory agencies to facilitate approval processes and support post-market surveillance.
• Partner with the R&D, Quality Assurance, Clinical Affairs, and Operations teams to ensure regulatory requirements are fully understood and integrated into product development processes.
2. Risk Management and Issue Resolution:
• Support risk management efforts related to regulatory compliance, ensuring that product-related issues are identified early, mitigated, and resolved in a timely manner.
• Address regulatory challenges, providing solutions to support business continuity, and managing any regulatory hurdles that may arise during product lifecycle management.
• Act as the primary point of contact for regulatory-related issues and provide expert advice on risk mitigation strategies.
3. External Engagement:
• Serve as the key regulatory liaison for North America in external stakeholder engagements, including regulatory bodies, industry associations, and standard-setting organizations.
• Represent Diasorin in industry forums and conferences, establishing and maintaining a thought leadership position in regulatory affairs.

Key Qualifications:

• Education:
• Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs. Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Experience:
• Minimum of 10 years of experience in regulatory affairs with at least 5 years of leadership experience.
• Proven experience in successfully managing regulatory submissions for Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions.
• In-depth knowledge of the regulatory landscape in North America (U.S. and Canada).
• Skills:
• Strong leadership and team management skills with a proven track record of mentoring and developing high-performing teams.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership.
• High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management.
• Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
• Other Requirements:
• Ability to travel as required for business needs.
• Strong proficiency in regulatory compliance tools, document management systems, and project management software.
• Demonstrated ability to drive results in a fast-paced, high-growth environment.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.