Director, Molecular Regulatory Affairs North America

diasorinsp•Austin, TX

10d

About The Position

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. 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.

Requirements

Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs.
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).
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.
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.

Nice To Haves

Certification in Regulatory Affairs (e.g., RAC) is a plus.

Responsibilities

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.
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.
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.
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.

Benefits

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.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.
Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [email protected].
Recruitment Fraud Notice
Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact [email protected] for verification.
Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.