RA Director NA, Compliance & Strategic Programs

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions advancing science to improve patient outcomes worldwide. For more than 50 years we have combined scientific rigor with an entrepreneurial mindset operating with a strong commitment to innovation accountability and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist Diasorin continuously invests in research technology and people. Guided by our values of operational excellence customer focus and teamwork we empower teams to think boldly act decisively and transform ideas into meaningful impact across one of the industrys broadest specialty diagnostic portfolios.

When you join Diasorin you are not just filling a role. You are helping build what comes next.

• Build What Matters
  Take ownership challenge the status quo and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed collaboration and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability inclusion and continuous development.

Job Scope

The RA Director NA Compliance & Strategic Programswill be responsible for directing Regulatory related activities for software/hardware of DiaSorin immuno and molecular units such as:

• Identifying new regulatory requirements and giving guidance for the local implementation ensuring the application of pertinent DiaSorin regulatory procedures
• Ensuring regulatory compliance of strategic projects
• Ensuring compliance with various regulation requirements and/or programs such as FDA Health Canada and state agencies.
• Interacts with regulatory agencies and ensures compliance with all applicable regulations including ISO Local State and Federal requirements where applicable.

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 SD&I Compliance & Strategic Projects Regulatory Affairs North America 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.

Duties and Responsibilities:

1. Cross Functional cooperation on Key projects:

• Support RA team in develop and implement regulatory strategies for the products 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.

2. Regulatory Compliance and Approvals:

• 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 pre Submissions 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.

3. 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.

Education Experience and Qualifications

• Advanced degree (MS PhD or equivalent) in Life Sciences Medical Device or Regulatory Affairs. Certification in Regulatory Affairs (e.g. RAC) is a plus.
• Minimum of 5 years of experience in regulatory affairs.
• Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products including FDA 510(k) PMA and Health Canada submissions.
• In-depth knowledge of the regulatory landscape in North America.

Training and Skills

• 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 offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits retirement and financial wellbeing time off programs wellbeing support and perks. Benefits may vary by role country region union status and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award if any depends on various factors including individual and organizational performance.

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 .

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 @ email address. If you have questions about the legitimacy of a recruitment communication please contact for verification.

Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.