Regulatory Affairs Specialist
vor 7 Monaten
Join us today and make a difference in people's lives
Regulatory Affairs Specialist (M/F/d)
Position Summary
The Regulatory Affairs Specialist implements and conducts the activities required to obtain and maintain regulatory clearance for the company's medical device products.
General Responsibilities
- Participating on project teams to provide input to ensure that appropriate regulatory requirements for market clearance or clinical trials are built into project plans
- Summarizing technical documents for regulatory submissions
- Responding to registration requests from regulatory authorities
- Maintaining regulatory files to ensure the company’s compliance with regulatory requirements
- Ensure local regulatory requirements are met prior to distribution
- Collaborate with regulatory representative(s) of international Distributors and/or Affiliates to ensure continued compliance with national regulations
- Work closely with Quality (and Clinical, as necessary) during audits/inspections
Skills and Experience
- A minimum of a BS in Engineering, Life Sciences, Pharmacy, Nursing or Mathematics/Statistics is required
- Some years’ experience working in a regulated environment industry such as a FDA Class 2 (or equivalent international classification) medical device manufacturer
- 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.
- Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.
- Good team player: open and honest when communicating among peers and management. Resolves most issues with peers, but understands what issues are important to escalate to management
- Strong interpersonal skills
- Appropriate written and verbal communication skills in English and in any other relevant language(s)
- Familiarity with medical industry terminology
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:
- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a _State-of-the-Art _medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognise and celebrate our colleagues’ contributions and achievements
Our commitment to Diversity & Inclusion:
- LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination._
Background Checks at LivaNova:
- Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check._
Notice to third party agencies:
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