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.

As we continue to grow, we are seeking a Senior Manager Regulatory Affairs who provides leadership oversight and accountability for pre and post-market regulatory strategies and translates those strategies into executable plans for the department/area of responsibilities and administer day-to-day Regulatory Affairs operations and manages or supports a team of managers and employess of different levels. The primary responsibility is to support new product development projects within the Transfusion Medicine Business Unit but may also support other Business Units if the need arises based on Company priorities.

This position can be based in Raritan, NJ or Rochester, NY. Remote work options will be considered.

• Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pending applications and resolve regulatory matters. Prepare and/or provide oversight to junior RA staff in the creation of submission content to meet regulatory agency expectations for IVD BLA and/or 510(k) regulated products, including biologic/device combination products.

• Support base business activities in a limited capacity as needed, such as Annual Reports, BLA Supplements, Labeling reviews, GUDID and Change Management reviews for regulatory submission impact. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.

• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements, submission content, indications of risk and approximate timing for application review/approval for planning purposes. Supports both new product development and currently marketed product portfolio within the Transfusion Medicine Business Unit.

• Represent Ortho to US regulatory agencies and interact with International Health Authorities to expedite pending applications, resolve regulatory matters, and manage development and pre-submission meetings for regulatory submissions.

• Provide support, as needed, for routine bi-annual FDA inspections, Pre-Approval Inspections or European Notified Body Inspections.

• Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies.

• Development goals, such as webinars, review FDA website and articles, read journals, attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff.

• Frequently responsible for relationship management

• Ability to provide Regulatory leadership in a matrixed organization

• Monitor US Regulatory landscape for updates and changes to regulations and guidances specific to CBER regulated products.

• Provide Regulatory guidance to project teams in the design and operation of CBER licensed manufacturing facilities.

• Perform other work-related duties as assigned.

• Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience.

• Direct BLA IND experience with demonstrated success resulting in positive outcomes.

• Minimum of 10+ years experience in an FDA regulated drug, biologic or IVD industry required. Biologic/Device combination experience a plus.

• Minimum of 7+ years hands-on submission experience including the developing and execution of regulatory strategies for drug, biologic and/or IVD regulated products is required, specific experience in biologics is preferred, but not required.

• 5+ years of people management experience is desired.

• RAC (Regulatory Affairs Certification) is a plus.

• Knowledge of US drug and/or biologic regulations is required and an understanding of EU regulations would be a plus. Specific knowledge of biologic IVDs and biologic IVD/device combinations will be given preferential consideration.

• Experience supporting NDA and/or BLA post-market CMC sections is preferred.

• Experience developing regulatory strategies is required and an understanding of product development is a plus.

• Ability to demonstrate model behavior, understands priorities and encourages others to drive for results is needed.

• Ability to mentor junior level staff as well as cross-train with peers. Ability to work with business partners across geographies and time zones is needed.

• Demonstrated regulatory expertise developed through experience and positive track record is required.

• Excellent interpersonal, teamwork and verbal/written communication skills are required. Good organizational skills and an ability to manage multiple tasks/projects/priorities is required.

• Experience in supporting regulatory filings requiring Pre-Approval Inspections (PAI) would be a plus.

• Up to 10-15% travel, domestic and international, required.

• Internal partners: Must maintain excellent working relationships with Domestic Regulatory Affairs colleagues, Product Managers, Project Leaders, R&D, Operations, Global Publications, International Regulatory Affairs, Marketing, and Quality / Compliance partners.

• External partners: Regulators, External KOLs, MD/Cybersecurity Consultants, External manufacturers, vendors/suppliers, Trade Associations, Auditors

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. This position's starting salary is between $99,000 and $198,000 per year, and it is bonus eligible. Salary will be determined by education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time) and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 their 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

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