Senior Regulatory Affairs Manager

The Role

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Regulatory Affairs Manager.

This role manages regulatory activities related to the development and approval of new in vitro diagnostics and medical devices into the worldwide market, as directed.

Responsibilities

• Manages new product development and U.S. submissions activities for a set of medical devices and/or IVD products.
• Works as primary core team member on new molecular product development teams and establishes regulatory strategy to achieve market clearance.
• Prepares, reviews and approves U.S. (FDA) product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations.
• Supervises interactions with government agencies for regulatory submissions.
• Reviews and approves verification and validation protocols and reports; advises on best practices for data presentation in regulatory submissions.
• Reviews and approves Marketing/Sales literature and labeling.
• Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections.
• Develops and presents training materials for regulatory requirements and/or department processes.
• Evaluates change control documents for impact on regulatory submissions and filing requirements, as needed.
• Researches regulations and competitor products and creates summaries for departmental use.
• Implements, manages, and continuously improves related regulatory processes, tools, and trackers.
• Ensures regulatory records are complete and well organized.
• Carries out duties in compliance with established business policies.
• Performs other duties & projects as assigned.

Individual Required

• Bachelor’s degree (BS/BA) in a scientific discipline
• Minimum of 12 years prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment
• Minimum of 12 years prior experience in Regulatory Affairs (or related educational/work experience) with progression of responsibility and leadership
• Prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions, international registrations, and EU technical documentation files. 510 (k) submission approvals required for molecular products and point of care products.
• Prior experience as a core team member on product development teams.
• Prior direct interaction with FDA and other regulatory agencies.
• Advanced knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment
• Advanced knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of medical devices (current FDA, QSR, ISO, CMDR, IVDR and other worldwide regulatory regulations as appropriate)
• Demonstrated ability to understand and make decisions for complex situations
• Demonstrated leadership in one or more regulatory affairs disciplines is required (for example, US Regulatory Submissions, International Regulatory Submissions, Post Market Regulatory Affairs, Labeling, Design Control, Permits and Licenses, Regulatory Operations).
• Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups
• High degree of accuracy and attention to detail
• Able to support Clinical, R&D, V&V, and PMO departments on an as needed basis in order to meet corporate objectives
• Able to work independently and be self-motivated
• Able to work under minimal supervision following established procedures
• Able to handle inter/intradepartmental issues in a cooperative and diplomatic manner
• Able to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations
• Able to work on multiple projects simultaneously
• Able to exercise judgment within defined procedures and practices to determine appropriate action
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio

Work Environment

Typical office environment, including home office.

Physical Demands

The work environment characteristics are representative of an office environment. No strenuous physical activity, although occasional light lifting of files and related materials is required. Occasional travel required. Travel may include airplane, automobile travel and overnight hotel.