Regulatory Affairs Specialist

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.

The 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

The Individual

Required:

• 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.

Preferred

• 10 years' prior experience specifically in IVD/Medical Device industry

• Strong competency with complex software systems and tools

• Strong competency in electronic data management

The Key Working Relationships

Internal Partners:

• Interacts with direct manager in Regulatory Operations to receive assignments and report on status of activities.

• Interacts with members of Regulatory Operations team to give and receive training and to collaborate on projects.

• Works with Document Control and Quality for implementation or modification of processes and procedures and ensuring regulatory compliance with internal quality systems

• Participates in cross-functional project teams and meetings between departments on specific issues.

External Partners:

• May interact with vendors for the implementation and management of Regulatory Affairs services and infrastructure

• May interact with domestic and international agencies in securing registrations, licenses, and certificates or to respond to inquiries (e.g., U.S. FDA, U.S. State Boards of Pharmacy, and Notified Bodies)

The Work Environment

Typical office environment including remote home office

The Physical Demands

No strenuous physical activity. Typically, majority of the time is spent at the desk on computer/doing paperwork and/or on the phone. Occasional travel required. Flexible work hours to meet project deadlines.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $77,399.06 - $85,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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