[Hiring] Senior Manager, Regulatory Affairs @QuidelOrtho

Role Description

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.

Responsibilities

• Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams.
• Interact with US FDA and/or EU Notified Body regulatory personnel 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 appropriate resources to achieve company and regulatory strategy objectives.
• Review/interpret product-specific regulatory issues that may impact the business, and develop strategic and tactical responses.
• Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel.
• 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.
• Coach, mentor junior staff.
• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements.
• Perform other work-related duties as assigned.

Qualifications

• 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.
• 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.
• Previous people management experience.
• Excellent interpersonal, teamwork, and verbal/written communication skills.
• Good organizational skills and an ability to manage multiple tasks/projects/priorities.
• Ability to mentor and coach junior level staff as well as cross-train with peers.

Requirements

• This position is not currently eligible for visa sponsorship.

Preferred

• 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.

The Key Working Relationships

• Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups.
• External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers.

The Work Environment

• Use of a computer is required.
• Traditional office workspace or remote home office location.
• On occasion, may require up to 20% of domestic/international travel.

Salary Transparency

The salary range for this position is $155,677.15 - $202,380.30 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.

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.