Overview
Position Summary:
This position is responsible for ensuring that pre‑market and/or post‑market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.
Responsibilities
Key Accountabilities
Essential Functions:
1. Advise and direct teams on regulatory requirements related to new product development or significant changes
2. Ensure test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s)
3. Author regulatory plans as regulatory lead for new products or significant product changes, including interfacing with country market approval holders to confirm local regulatory requirements
4. Act as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and international
5. Review and approve labeling and marketing materials associated to regulatory filings
6. Advise and direct teams on regulatory requirements for on-market product changes
7. Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements
8. Ensure company site and device registrations are compliant with applicable domestic and international regulations
9. Review and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as required
10. Increase working knowledge of regulations, standards, company SOPs and tools
11. Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management
12. Assist in tracking standards, regulations and all applicable requirements
13. Other duties as assigned
Secondary Functions:
14. Assesses regulatory gaps and take the appropriate corrective actions, as needed
15. Supports internal and external audit as required
16. Participates in regulatory improvement projects as required
Budget Managed (if applicable)
17. N/A
Internal Networking/Key Relationships
To be determined based on department needs, to include interactions such as:
18. Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirements
19. Ability to negotiate and influence others in establishing direction toward improved regulatory and enhanced compliance
20. Ability to effectively communicate regulatory requirements to a broad population of constituents
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
21. Ability to read and interpret domestic and international regulatory/quality standards related to our products
22. Working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements
23. Demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectives
24. Recognition of when to escalate issues to management or consult with more senior staff members.
Competencies:
25. Attention to Detail: Ability to pay close attention to detail is required
26. Accuracy: Work is accurate and complete
27. Performance Standards: Demonstrated ability to meet department goals
28. Communication: Excellent written, verbal and presentation skills
29. Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
30. Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
31. Collaboration: Ability to work within a team to bring best solutions to the team or customer
32. Independence: self-motivated-works under minimal supervision
33. Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
34. Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
35. Problem Solving: Promptly and effectively handles issues and problems
36. Decision Making: Makes decisions based on data and risk determination
Qualifications
Minimum Knowledge & Experience Required for the Position:
Education:
37. Bachelor's degree or higher, preferably in science and/or regulatory
Experience:
38. Minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degree
Additional Skills/Knowledge:
39. Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulations
40. Understanding of the application of regulatory principles in the areas of pre-market or post-market compliance
41. Knowledge of FDA, ISO, MDSAP and international country regulations
42. Knowledge of design control requirements and understanding of GMP
43. Language: English
International Mobility:
44. Required: No
Travel Requirements:
45. <10% of time
The annual base salary range for this role is currently $K to $K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen