Senior Regulatory Affairs Specialist

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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.
  

JOB SUMMARY

Prepare regulatory assessments of product changes, documenting rationale, actions and following through with notifications internationally as needed. An advanced Regulatory Specialist that will provide pre-market regulatory strategy planning and implementation to ensure regulatory requirements are incorporated and approval/clearance/authorization is obtained for new and modified products. Assure that DiaSorin products/processes comply with global in vitro diagnostic medical device and import/export regulations. Continue to expand knowledge of regulations as well as mentor others, key contributor in company projects on core teams with the potential for project management roles. Opportunities for growth as an author, project manager, leader based on demonstrated knowledge and performance.

Key Responsibilities and Duties

• Prepare regulatory assessments of product changes, documenting rationale, actions and following through with notifications internationally as needed.
• Create/ revise/ review and submit Annual Reports for US and Canada.
• Create, revise, review, and maintain regulatory compliance for labels and IFUs.
• Use a variety of systems to complete tasks and maintain records.
• Provide international STED submissions and requested declarations and other documentation to subsidiaries/distributors to obtain and maintain registrations.
• Update European/international technical files as needed when there are changes to products, testing, manufacturing, claims, file requirements or labeling.
• Be accountable in maintaining quality work and supporting a work environment of continuous improvement to increase efficiency, quality and compliance.
• Submit Canadian license applications and amendments.
• Assist with other duties as opportunities arise. Submit product and quality system changes to the notified body.
• Participate in regulatory training and transfer the information back to the Regulatory department providing insightful application.
• Communicate regulatory information to assist with trade compliance, CDC, and import/export activities.
• Author 510(k) and Pre-Market Approval (PMA) submissions and perform reviews for submissions at other DiaSorin sites.
• Represent Regulatory on core teams providing regulatory guidance throughout the product development cycle.
• Support special projects or strategic initiatives as requested by the business.
• Review updates to regulations, guidance, and standards to determine the impact to regulatory processes; responsible for distribution of US updates.
• Author procedures and train on compliance to US and international regulations on promotional materials and off label use policy.
• Lead projects, coordinating resources and ensuring appropriate inputs to obtain timely and effective outputs.
• Author procedures, train and lead compliance with regulations, standards, guidance and notified body feedback.
• Review regulations, external standards, and guidance to interpret them and apply relevant information to DiaSorin processes.

Qualifications

• Bachelor's degree in life science or engineering required
• Master's Degree in life science or engineering, preferred
• 5+ years in Regulatory medical device experience, at least several years in IVD, doing US, European, and or international submissions Required
• Prior experience in interacting with FDA staff and/or other regulatory agencies and demonstrated success in securing regulatory approvals.
• Experience authoring procedures and determining applicable
• regulations/standards/guidance for products/processes.
• Experience in authoring of IVD 510(k), PMA, EU IVDR, and Canada licenses
• Certification in Regulatory Affairs Certifications (RAC)-RAPS, preferred
• Knowledge of US, European, international regulations and standards, and experience in
• preparing regulatory submissions
• Proven analytical capabilities, solid understanding of manufacturing and change control, and good manufacturing practices.
• Ability to speak effectively before groups of customers or employees of organization and ability to organize information to compose reports, documents and presentations.
• Knowledge/Understanding of USDA, CDC, import/export requirements for imported animal/human raw materials and finished goods
• Ability and willingness to train, establish measure of effectiveness, and follow through further if needed.
• Understands mathematics, general statistics, confidence intervals, sampling techniques, conversions
• Ability to think creatively given competing requests to determine options that satisfy multiple viewpoints.

What we offer/Salary Range

The salary range for this position is $80,300-$117,500 annually. 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.