Senior Director, NA Regulatory Affairs Program Strategy

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

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 Senior Director of Regulatory Affairs to support the 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 Senior Director of Regulatory Affairs, North America, will be responsible for supporting all regulatory functions and activities related to Immuno and Molecular Diagnostics products across North America. This leadership role will ensure full support in identifing regulatory strategies to be aligned with company goals and the evolving regulatory environment in the healthcare industry. The Senior Director 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:
o Support RA team in develop and implement regulatory strategies for the Immuno and Molecular Diagnostics portfolio in North America, ensuring timely market access for all new products and continued compliance for existing products.
o Support the team, fostering a high-performance culture and a deep understanding of regulatory requirements and industry standards.
o Identifying potential risks and opportunities, and ensuring alignment with global corporate objectives.
o Stay abreast of industry trends and regulatory changes impacting product approval processes, quality standards, and market access requirements in the U.S. and Canada.
2. Regulatory Compliance and Approvals:
o In conjunction with RA team assure Compliance in submissions and approvals for new Immuno and 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, CE marking (when applicable), and other relevant filings as required by regulatory authorities.
o Partner with RA team in the preparation and submission of regulatory documents, ensuring that all submissions meet regulatory requirements and are completed on time.
o Establish and maintain relationships with key regulatory agencies to facilitate approval processes and support post-market surveillance.
o 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.
3. Risk Management and Issue Resolution:
o Lead risk management efforts related to regulatory compliance, ensuring that product-related issues are identified early, mitigated, and resolved in a timely manner.
o Address regulatory challenges, providing solutions to support business continuity, and managing any regulatory hurdles that may arise during product lifecycle management.
o Act as point of contact for regulatory-related issues and provide expert advice on risk mitigation strategies.
4. External Engagement:
o Serve as the key regulatory liaison for North America in external stakeholder engagements, including regulatory bodies, industry associations, and standard-setting organizations.
o Represent Diasorin in industry forums and conferences, establishing and maintaining a thought leadership position in regulatory affairs.
Key Qualifications:
• Education:
o 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:
o Minimum of 10 years of experience in regulatory affairs with at least 5 years of leadership experience.
o Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions.
o In-depth knowledge of the regulatory landscape in North America (U.S. and Canada) and a strong understanding of global regulatory requirements (e.g., EU, APAC).
• Skills:
o 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.
o High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management.
o Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
• Other Requirements:
o Ability to travel as required for business needs.
o Strong proficiency in regulatory compliance tools, document management systems, and project management software.
o Demonstrated ability to drive results in a fast-paced, high-growth environment.

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, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.