Senior Regulatory Affairs Manager

QuidelOrtho; New York (NY); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Employee Stock Purchase Plan

Job summary

QuidelOrtho is seeking a Senior Regulatory Affairs Manager to drive regulatory strategy and execution across clinical laboratory and transfusion medicine products. You will partner with R&D, Quality, Manufacturing, and global teams to ensure timely submissions and compliance across development and lifecycle stages.

The role focuses on leading regulatory plans, managing risks, and delivering high-quality documentation for FDA, EU IVDR, and international authorities.

Qualifications

• Bachelor’s degree required.
• 7+ years of regulatory affairs experience in medical devices/diagnostics.
• Proven track record leading regulatory submissions (510(k), PMA, BLA, CE).
• Strong knowledge of FDA, EU IVDR, and international requirements.
• Excellent communication and project management skills.

Responsibilities

• Interpret regulatory requirements to support product registrations.
• Maintain regulatory plans aligned with project needs.
• Track commitments and ensure timely execution across programs.
• Prepare and submit regulatory filings (FDA, EU, and international).
• Ensure complete, scientifically sound documentation.
• Monitor changes in global regulations and advise teams.

Skills

Regulatory leadership

FDA regulations

Cross-functional collaboration

Project management

Education

Bachelor's degree

Advanced degree preferred

Job description

The Opportunity

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 Responsibilities

• 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 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

The Work Environment

Typical office environment, including home office.

The Physical Demands

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%.

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 $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.

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 [e-mail].