Team Leader, Regulatory Affairs

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!

Job Scope

Provides regulatory strategy and direction to the business regarding IVD regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally, and in line with corporate strategy and requirements. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Job Tasks and Responsibilities

• Develops regulatory strategies to help get market authorizations, taking into consideration business needs: target countries, clinical claims and timing expected. Helps identify and elaborate necessary product testing and clinical studies as needed. Researches, analyzes and organizes scientific data to support the evidence that the benefits of the medical device outweighs the risks.
• Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch, in alignment with the approved Regulatory Master Plan. Countries in scope are global: Latin America, Europe, China and other Asian countries.
• Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
• Assesses design changes on existing products and determines the need for new / revised licenses or registrations.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Participates in regulatory intelligence and help communicate new regulatory requirements to development teams.
• Supports regulatory and quality system inspections as required
• Prepares, reviews and approves internal procedures to ensure compliance to regulatory and quality system requirements, in alignment to Group Operating Procedures as applicable.

Education and Experience Qualifications

• Bachelor’s Degree or a minimum of 3 years work experience in a regulated industry or medical device industry required. Advanced degree in scientific, technology or legal disciplines preferred.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications required.
• Ability to prioritize activities, to plan and execute to get deliverables in time.
• True ability to operationalize analytical skills in an highly-regulated environment.
• Ability to communicate effectively in English (both written and oral).
• Problem-solving and negotiation skills.

The hiring range for this position is $130,100 - $162,625 per year. 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.

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.