Orthoclinical

Sr Regulatory Affairs Specialist

US · Senior

H1B sponsorship available$105k-$120kDetected 7 days ago

ComplianceExcelGMPFDA RegulatoryMedical DevicesResearchLeadershipMicrosoft OfficeRegulatory Affairs

About the role

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.
Join us in our mission to transform the power of diagnostics into a healthier future for all.

Interact with cross functional partners to manage registration activities.
Interacts with project teams to provide guidance and complete regulatory deliverables for the product development process and regional business partners.

Bachelor's degree (BS/BA) in a scientific discipline
Must have prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) pre-subs, international registrations, and EU technical documentation files.
Must have prior experience as a core team member on product development teams.
Must have prior direct interaction with FDA and other regulatory agencies.
Advanced knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment
Demonstrated ability to understand and make decisions for complex situations
Ability to work cohesively with multi-disciplinary scientific working groups
Must possess a high degree of accuracy and attention to detail.
Ability to work independently and be self-motivated
Ability to work under minimal supervision following established procedures

IVDR submission and gap assessments experience
Supervises interactions with government agencies for regulatory submissions.
Reviews and approves Marketing/Sales literature and labeling.
Worked on Corporate initiatives for organizational improvements, such as standards management.
Works with RIMS system and is proficient in data gathering and maintenance of a RIMS system.
Ensure regulatory records are complete and well organized.

Typical office environment, including home office.
The salary range for this position is $105,000 to $120,000 and is bonus eligible.
All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Join our mission as our next The Senior Regulatory Affairs Specialist.
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.

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.
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.

This listing is sourced directly from Orthoclinical's careers page and normalized into a canonical job model.