New · posted Oct 15
QuidelOrtho · Medical Devices
Senior Regulatory Affairs Manager
- Remote, US
- Remote
- Full-time
- Manager
Open until filled
The role
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
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. The Senior Regulatory Affairs Manager is responsible for driving the planning, execution, and delivery of regulatory activities supporting clinical laboratory and transfusion medicine products across development and lifecycle stages. This role partners closely with cross-functional teams and global regulatory stakeholders to ensure timely submissions, regulatory compliance, and alignment with product development objectives.
Serving as a key contributor to regulatory strategy, the Sr RA Manager translates regulatory requirements into actionable plans, manages timelines and deliverables, and identifies risks while supporting informed decision-making. This role also ensures high-quality preparation and submission of scientifically sound regulatory documentation to health authorities, including FDA, EU Notified Bodies, and international agencies.
The Sr Regulatory Affairs Manager plays a critical role in enabling operational excellence, maintaining compliance with evolving global regulations (including EU IVDR requirements), and contributing to continuous improvement initiatives within the regulatory function, while supporting team collaboration and development.
The Senior Regulatory Affairs Manager develops, communicates, and executes regulatory strategies for clinical laboratory and transfusion medicine products across development and lifecycle management. This role supports regulatory operations and strategic initiatives while collaborating with cross-functional teams and global regulatory partners to ensure compliance and timely product registrations. The position contributes to regulatory excellence by aligning program deliverables with organizational goals and maintaining awareness of regulatory risks and requirements.
The Senior Regulatory Affairs Manager is responsible for planning, tracking, and delivering regulatory milestones, ensuring alignment with project timelines, and supporting leadership in identifying and escalating key regulatory risks and compliance issues.
This position is remote eligible for candidates located in the United States.
The Individual
Required:
Bachelor’s degree required
7 years plus of extensive experience in regulatory affairs within the medical device or diagnostics industry
Proven track record as RA Functional Core Team Lead, and managing complex regulatory submissions
Strong background in FDA, EU IVDR, and international regulatory requirements
Deep understanding of FDA regulations, EU IVDR, and international regulatory requirements
Knowledge of product registration processes and compliance requirements
Experience with regulatory submissions including 510(k), PMA, BLA, and TDF CE marking processes
Understanding of clinical performance studies and regulatory documentation requirements
Program Management:
Advanced program and project management expertise, with a track record of successfully managing multiple, concurrent priorities in fast-paced, cross-regulatory environments
Exceptional communication and presentation skills, with the ability to translate complex regulatory concepts for both technical and non-technical stakeholders
Proven ability to drive alignment and execution through effective collaboration across cross-functional teams, including R&D, clinical, quality, operations, legal, and commercial functions
Strategic Thinking:
Ability to develop and implement regulatory strategies aligned with business objectives
Strong analytical skills for risk assessment and strategic option evaluation
Understanding of global regulatory landscapes and market requirements
This position is not currently eligible for visa sponsorship.
Preferred:
Advanced degree preferred in relevant scientific, regulatory, or related field
Experience with clinical laboratory devices and transfusion medicine products
Key Working Relationships
Internal Customers:
R&D departments, Business Units, Quality, Manufacturing, Clinical teams, Legal, International Regulatory Affairs
External Customers:
External consultants and regulatory agencies
What you need
What you'll do
Interpret applicable regulatory requirements and apply them to project-level strategies to support compliance and product registration
Maintain and update regulatory plans, ensuring alignment with evolving project needs and regulatory expectations
Assess risks, trade-offs, and strategic options, and communicate recommendations to project teams and management
Track regulatory commitments and ensure timely execution across assigned programs
Support preparation and coordination of regulatory activities in partnership with internal teams and external stakeholders
Prepare, review, and submit regulatory filings (e.g., FDA submissions, EU Technical Files, and international dossiers) in accordance with applicable requirements
Ensure documentation is complete, accurate, scientifically sound, and compliant with regulatory standards
Monitor, assess, and communicate changes in global regulations, guidance, and standards relevant to assigned product areas
Provide regulatory input and guidance to project teams during product development and lifecycle management
Collaborate with international regulatory colleagues to support global submissions and approvals
Collaborate with regulatory leadership to support team objectives and resource planning
Provide guidance and mentorship to junior regulatory staff as needed
Coordinate activities with consultants, contractors, and external partners
Promote a culture of continuous improvement and knowledge sharing within the regulatory function
Support compliance with EU IVDR requirements, including maintenance of technical documentation and declarations of conformity
Assist in ensuring required documentation and statements for performance studies are prepared and maintained in alignment with Annex XIV and Article 15 responsibilities
Perform additional duties as assigned to support regulatory and organizational objectives
The Work Environment
Typical office environment, including home office.
Pay and benefits
$150,000 – $170,000 a year
Employer providedSalary 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 $150,000 - $170,000 annually 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.
Medical, dental and vision insurance
Life and disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off and paid holidays
Working conditions
Sitting or standing at a desk. Talking, hearing, vision, typing. Time is split between meetings and working independently. Occasional domestic & international travel may be required for regulatory meetings, conferences, and coordination with international affiliates and partners.Travel includes airplane, automobile travel and overnight hotel. Estimated travel 35%.
Equal opportunity, accessibility and legal noticesQuidelOrtho's statements, word for word
Equal Employment 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. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $150,000 | — | $170,000 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: QuidelOrtho's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not QuidelOrtho's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 51 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership16
- Regulatory submissions10
- GMP and compliance9
- Documentation and SOPs7
- Lab testing and methods5
- Quality systems and risk3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
QuidelOrtho on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Senior & Principal2 67%
- Manager1 33%
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Senior Regulatory Affairs Manager at QuidelOrtho
Open until filled. $150K–$170K a year, employer provided.