Senior Manager, Regulatory Affairs

Role Overview

• Manage and support a team of managers and employees of different levels.
• 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.
• 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.

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.

Benefits

• medical, dental, vision, life, and disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• paid Holidays