Senior Regulatory Affairs Specialist
Full Job Description
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics. We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
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 Duties and Responsibilities
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, guidances and notified body feedback.
Review regulations, external standards, and guidances to interpret them and apply relevant information to DiaSorin processes.
Other Duties and Responsibilities
Education, Experience, and Qualifications
Bachelors Degree in life science or engineering.
5 years minimum Regulatory medical device experience, at least several years in IVD, doing US, European, and or international submissions
Prior experience in interacting with FDA staff and/or other regulatory agencies and demonstrated success in securing regulatory approvals.
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.
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 preferred.
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.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.
Equal Employment Opportunity
Posters: https://www.dol.gov/agencies/ofccp/posters .
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: email@example.com . If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: firstname.lastname@example.org or call toll-free 1.800.328.1482.
Your application has been successfully submitted.