As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.
Principal Regulatory Affairs Specialist (m/f/d)
General Responsibilities
1. Participating on product development project teams to provide input to ensure that appropriate regulatory requirements for market clearance or clinical trials are built into project plans.
2. Developing regulatory submission applications to introduce new or modified devices, new or expanded indications for use or changes to the manufacturing/quality processes into the marketplace.
3. Participating in meetings with regulatory officials for purposes related to market approval.
4. Providing senior management practical operations-oriented interpretation of regulatory requirements governing medical devices.
5. Responding to registration requests from regulatory authorities.
6. Reviewing advertising and promotional literature.
7. Maintaining regulatory files to ensure the company’s compliance with regulatory requirements.
8. Implementing initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth without adversely impacting quality or regulatory compliance.
9. Developing and reviewing quality system documentation such as Clinical and Regulatory strategic plans, procedures, verification and validation protocols and reports, investigation (e.g., complaint or CAPA) and clinical protocols and study reports.
10. Collaborating with Clinical Affairs, Product Development, Quality, Marketing and Operations to drive best practices into project and fulfill design control activities and other Product Development Projects / New Products deliverables in a timely manner.
11. Ensure local regulatory requirements are met prior to distribution.
Skills and Experience
12. A minimum of a BS in Engineering, Life Sciences, Pharmacy, Nursing or Mathematics/Statistics is required.
13. Graduate degrees in biomedical or clinical engineering (Research-based MS and PhD) from recognized university programs are preferred.
14. Several years experience working in a regulated environment industry such as FDA/ EU MDR Class 2 or 3 (or equivalent international classification) medical device manufacturer.
15. Possesses appropriate knowledge of pertinent regulations to assure regulatory submissions and the departments procedures meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfill such requirements.
16. Understanding of basic clinical and regulatory principles including, but not limited to: clinical trial design and methodology and knowledgeable of world-wide clinical and regulatory environments we compete in.
17. Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.
18. Time management: able to independently manage large technical writing projects to complete per schedule
19. Strong interpersonal skills. Able and willing to challenge technical and strategic approaches.
20. Strong written and verbal communication skills in English and in any other relevant language(s).
21. Strong technical writing skills; able to efficiently and effectively write large submissions in English
22. Proficient in MS Office including Word, Power Point, and Excel
23. Travel up to 25 %
What we can offer you
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
24. A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
25. Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
26. Competitive base salary
27. Variable short-term & long-term incentives
28. Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
Welcome to impact. Welcome to innovation. Welcome to your new life.