[Hiring] Senior Regulatory Affairs Specialist @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 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.
• 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.

Qualifications

• 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.
• Demonstrated ability to understand and make decisions for complex situations.
• Demonstrated leadership in one or more regulatory affairs disciplines.
• 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.
• 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.
• 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.

Requirements

• 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

• 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, which may include airplane, automobile travel, and overnight hotel stays.

Salary Transparency

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.

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.