Regulatory Affairs Specialist II

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  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.
  

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  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.
  

The Regulatory Affairs Specialist II is responsible for developing and executing pre-market regulatory strategies to support global commercialization initiatives for new and modified products. This role ensures compliance with U.S., Canadian, European, and international regulatory requirements, including FDA, Health Canada, IVDR/IVDD, and other relevant regulatory bodies. The ideal candidate possesses a strong understanding of in vitro diagnostics (IVD) standards, regulatory submissions, and cross-functional collaboration to drive successful product approvals.

• Serve as a regulatory subject matter expert on core teams, providing guidance throughout the product development lifecycle, from concept to market introduction.
• Develop and implement global regulatory strategies, ensuring alignment with business objectives and compliance with evolving regulatory landscapes.
• Partner with R&D, Quality, Manufacturing, and Marketing to assess regulatory impacts of product modifications, process changes, and new product launches.
• Conduct regulatory risk assessments and gap analyses to identify potential challenges and proactively develop solutions.

• Prepare, review, and manage regulatory submissions such as:
  
  
  
  • U.S. FDA: 510(k) Notifications, Pre-Market Approvals (PMA), De Novo applications.
  • European Union: IVDR Technical Documentation.
  • Health Canada, LATAM, APAC, and other global markets - product registrations and approvals.
  
  
  
  
• Liaise with regulatory authorities (FDA, Health Canada, Notified Bodies, etc.), responding to inquiries and providing necessary documentation.
• Maintain regulatory documentation and compliance tracking systems to support audit readiness and post-market surveillance activities.

• Ensure all product labeling, marketing materials, and advertising claims comply with applicable regulatory requirements.
• Monitor and interpret global regulatory trends, standards, and guidances, ensuring organizational awareness and adaptation to evolving regulations.
• Oversee trade compliance processes, ensuring adherence to import/export regulatory requirements.
• Participate in internal and external audits, supporting responses and corrective action plans as needed.

• Identify and implement process efficiencies in regulatory operations to optimize submission timelines.
• Provide mentorship and regulatory guidance to junior team members.
• Collaborate with Quality Assurance, Clinical, and Legal teams to ensure regulatory compliance across the product lifecycle.

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field required.
• Minimum 3+ years of regulatory affairs experience in the medical device, biotechnology, or in vitro diagnostics (IVD) industry.
• Regulatory Affairs Certification (RAC) preferred, particularly for candidates with fewer than five years of experience.
• Experience working on projects from early-stage development through commercialization.
• Direct experience with U.S. FDA, Health Canada, EU IVDR, and other international regulatory submissions.

• Strong understanding of global regulatory frameworks, including FDA QSR, ISO 13485, IVDR, and MDSAP.
• Experience in preparing and submitting 510(k), PMA, or international dossiers.
• Familiarity with clinical evidence requirements, risk management, and post-market surveillance obligations.
• Proficiency in regulatory database management, electronic submissions, and document control systems.
• Strong analytical skills with the ability to assess regulatory risks, trends, and strategic pathways for market entry.

• Strong problem-solving, critical thinking, and decision-making capabilities.
• Excellent written and verbal communication skills for internal and external stakeholder engagement.
• Ability to work both independently and collaboratively in a fast-paced, cross-functional environment.
• Detail-oriented, organized, and able to manage multiple priorities effectively.
• Ability to influence and negotiate with internal teams and regulatory authorities.

What We Offer/Salary

Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world. The salary range for this position is $57,000 - $92,000. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, 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.