The Role

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next The Senior Regulatory Affairs Specialist. 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. Reviews and approves U.S. and IVDR regulatory submissions. Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Promotes awareness of applicable regulatory and customer requirements to cross functional partners during new product development and life cycle management projects.

This role is remote eligible.

The 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 point of care and molecular product development teams and establishes regulatory strategy to achieve market clearance.
• Prepares, reviews and approves U.S. (FDA) and/or global product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations.
• IVDR submission and gap assessments experience
• Supervises interactions with government agencies for 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.
• Worked on Corporate initiatives for organizational improvements, such as standards management.
• Works with RIMS system and is proficient in data gathering and maintenance of a RIMS system.
• 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.
• Research regulations and competitor products and create summaries for departmental use.
• Implements, manages, and continuously improves related regulatory processes, tools, and trackers
• Ensure regulatory records are complete and well organized.
• Carries out duties in compliance with established business policies.
• Perform other work-related duties as assigned

The Individual

Required:

• Bachelor's degree (BS/BA) in a scientific discipline
• Minimum of 4 years prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment
• Minimum of 3 years prior experience in Regulatory Affairs (or related educational/work experience) with progression of responsibility and leadership
• Must have prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) pre-subs, international registrations, and EU technical documentation files.
• Must have prior experience as a core team member on product development teams.
• Must have 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 (for example, US Regulatory Submissions, International Regulatory Submissions, Post Market Regulatory Affairs, Labeling, Design Control, Permits and Licenses, Regulatory Operations).
• Ability to work cohesively with multi-disciplinary scientific working groups
• Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups
• Must possess a high degree of accuracy and attention to detail.
• Ability to support Clinical, R&D, V&V, and PMO departments on an as needed basis in order to meet corporate objectives
• Ability to work independently and be self-motivated
• Ability to work under minimal supervision following established procedures
• Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner
• Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations
• Ability to work on multiple projects simultaneously
• Ability to exercise judgment within defined procedures and practices to determine appropriate action
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio
• This position is not currently eligible for visa sponsorship.

Preferred:

• BS/BA in a biological science
• Minimum of 2 years' experience in the IVD or medical device manufacturing environment
• Demonstrated technical expertise with immunoassay and molecular diagnostics

The Key Working Relationships

Internal Partners:

Interact with cross functional partners to manage registration activities. Interacts with project teams to provide guidance and complete regulatory deliverables for the product development process and regional business partners. Works with Quality management to ensure regulatory compliance with internal quality systems. Participates on task forces and meetings between departments on specific issues.

The Work Environment

Typical office environment, including home office.

The 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.

Salary Transparency

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. The salary range for this position is $105,000 to $120,000 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. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.