Senior Regulatory Affairs Associate

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

The Senior Regulatory Affairs Associate will be responsible for:

Individual contribution for both pre and post market compliance with global medical device regulations. Compliance activities including keeping current with standards, guidance documents, training and regulatory publications, adherence to hazardous substance requirements, labeling requirements where Diasorin Molecular products are being marketed and a supportive role in product registration efforts, regulatory impact analyses of changes and potential recall investigations. Assisting with activities that support rapid entry into new markets upon development of new products and to maintain existing products. Developing 510k, Pre-Submission and IDE submissions, and ensures timely regulatory filings and documentation processes including technical files.

Key Responsibilities and Duties

• Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval  (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices.
• Prepare and assist in review and submission of regulatory submissions, product registrations and technical dossiers to Notified Bodies and Health Canada.
• Prepare appropriate documentation for product CE mark certification.
• Maintain regulatory documentation, registrations and device listings for both domestic and outside the US (OUS). Maintain international regulatory submission technical files, registrations/licenses, device listings and design dossiers for CE marking, and those required for Canada and other international countries outside the US.
• Interact effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring that departmental timelines are met. Communicate and coordinate regulatory activities with other departments.
• Prepare and evaluates regulatory documents and company specific SOP's to maintain FDA QSR and ISO 13485 compliance.
• Provide appropriate regulatory guidance to research and operations staff.
• Review and provide input to device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
• Review of product and manufacturing changes and compliance with applicable regulations.
• Review of protocols and reports to support regulatory submission and product changes.
• Participate on interdepartmental teams where required, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
• Participate in compliance activities that relate to the department and the company as a whole.
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
• Write/revise departmental SOPs as required
• May assist with training and mentoring other RA associates and staff
• Other duties as assigned

Education, Experience, and Qualifications

• Bachelor's Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology or equivalent
• Master’s Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology or equivalent preferred
• 4+ years Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
• 4+ Years Experience as a Technician / Scientist or related biological discipline
• 1+ Years Experience with in vitro medical devices
• 1+ Years Experience working independently in a fast-paced environment with rapidly changing priorities
• Certification in Regulatory Affairs/Quality considered to be an asset (RAQC, RAC, ASQ CQA, etc.)
• Thorough knowledge of cGMP regulations and ISO13485 standard for quality management systems
• Ability to effectively contribute to and lead cross-functional project teams
• Strong written and oral communication skills
• Highly organized and detail –oriented with exceptional proven time management and prioritization skills
• Results and goal oriented Ability to work independently and with minimal supervision in a fast paced and dynamic environment
• Ability to handle the pressure of meeting tight deadline

What we offer

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.

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.