Regulatory Affairs Principal
Danaher Corporation
Summary
The Regulatory Affairs Principal is responsible to serve as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects and/or system projects.
Job description
In this role, you will have the opportunity to:
- Prepare regulatory submissions and interact cross-functionally to ensure on time delivery (OTD) of product launches.
- Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required.
- Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU, with focus on software and cybersecurity.
- Implements continuous improvements and efficiencies using DBS tools.
The essential requirements of the job include:
- Bachelor’s degree in applicable field with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience
- Serves as RA lead on new product (NPD) core teams including medium to complicated instrument or software projects and submissions (510(k), De Novo, Class A, B, C or D) and collaborate with assay teams.
- Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for software and hardware submissions, including software development, cybersecurity and EMC deliverables, that are in scope for the initial product launch (US, EU, WHO/PQ).
- Authors, prepare, and support regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.
- Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status.
It would be a plus if you also possess previous experience in:
- Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines.
- Compiling, preparing, reviewing, supporting, and submitting regulatory submissions including FDA pre-submissions, 510(k), PMA submissions, and EU Technical Documents that include software and hardware including cybersecurity deliverables.
- Critical review of software and hardware protocols, reports and deliverables to assess quality, clearly identify gaps, and provide mitigations and actions to core team.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel as needed for training, agency meetings, or support at additional Cepheid sites as needed, approximately 15% travel.
Requirements
- Bachelor’s degree in applicable field with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience
- Serves as RA lead on new product (NPD) core teams including medium to complicated instrument or software projects and submissions (510(k), De Novo, Class A, B, C or D) and collaborate with assay teams.
- Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for software and hardware submissions, including software development, cybersecurity and EMC deliverables, that are in scope for the initial product launch (US, EU, WHO/PQ).
- Authors, prepare, and support regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.
- Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status.
- Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines.
- Compiling, preparing, reviewing, supporting, and submitting regulatory submissions including FDA pre-submissions, 510(k), PMA submissions, and EU Technical Documents that include software and hardware including cybersecurity deliverables.
- Critical review of software and hardware protocols, reports and deliverables to assess quality, clearly identify gaps, and provide mitigations and actions to core team.
- Ability to travel as needed for training, agency meetings, or support at additional Cepheid sites as needed, approximately 15% travel.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.