Senior Manager, Regulatory Affairs

QuidelOrtho

1d•Remote

About The Position

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. At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL

Requirements

Bachelor’s degree in a scientific or related discipline; or equivalent combination of education and experience.
10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry.
7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports).
Review and approval of product labeling and promotional and advertisement brochures and multimedia content.
Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s).
Previous people management experience.
Excellent interpersonal, teamwork, and verbal/written communication skills.
Good organizational skills and an ability to manage multiple tasks/projects/priorities.
The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed.
Ability to mentor and coach junior level staff as well as cross-train with peers.
This position is not currently eligible for visa sponsorship.

Nice To Haves

Direct experience with FDA CBER.
Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both.
RAC (Regulatory Affairs Certification).
Medical Device and/ or Pharmaceutical Industry experience is highly desirable.
CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus.
Use of Process Excellence (PEx) tools for process improvement initiatives.

Responsibilities

Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks.
Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters.
Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed.
Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives.
Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment.
Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions.
Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies.
Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs.
Coach, mentor junior staff.
Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes.
Perform other work-related duties as assigned.