Regulatory Affairs Specialist
About The Position
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Regulatory Affairs Specialist. The Regulatory Affairs Specialist is a member of the Regulatory Operations group and assists with building and maintaining infrastructure and processes for operating the Clinical/Regulatory/Medical/Assay V&V department. Regulatory Operations provides infrastructure to the broader department through the creation and continuous improvement of regulatory processes, implementation and maintenance of regulatory software systems, and management of centralized regulatory services and support functions. This position will be located in San Diego, CA.
Requirements
- 7 years’ prior experience in IVD, Medical Device, Pharmaceuticals, or Biologics industries
- 15 years of administrative assistant experience
- 2 years of regulatory and quality experience (or equivalent)
- Strong competency with Microsoft Office applications, pdf publishing, and electronic document management systems
- This position is not currently eligible for visa sponsorship.
Nice To Haves
- 10 years’ prior experience specifically in IVD/Medical Device industry
- Strong competency with complex software systems and tools
- Strong competency in electronic data management
Responsibilities
- US State licenses, US FDA registrations, EUDAMED registrations, and/or other domestic or international facility registration processes managed by Regulatory Operations.
- External standards control and government database entries (GUDID and EUDAMED)
- Working cross functionally to provide decisions on orders in the SAP system and update the license information.
- Integrating RA approvals and responsibilities in QMS documentation.
- Responsible for invoices within the RA operation group
- FURLS updates and annual renewals
- Other centralized regulatory services.
- Organizes regulatory records in eDMS, including US 510(k) files, CLIA Waiver Application files, international registration files, technical files, licenses, certificates, and reports.
- Routes draft documentation in the electronic document management systems (eDMS) to department staff for review and approval.
- Maintains trackers and reports on status of regulatory operations projects to management.
- Assists with department metrics gathering and producing monthly reports for management.
- Performs other work-related duties as assigned
Benefits
- medical, dental, vision, life, and disability insurance
- 401(k) plan
- employee assistance program
- Employee Stock Purchase Plan
- paid time off (including sick time)
- paid Holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
