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Join us today and make a difference in people's lives
The Regulatory Affairs Specialist (M/F/d) implements and conducts the activities required to obtain and maintain regulatory clearance for the company's medical device products.
**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
- Participating in meetings with regulatory officials for purposes related to market approval.
- Providing senior management practical operations-oriented interpretation of regulatory requirements governing medical devices
- Responding to registration requests from regulatory authorities
- Reviewing advertising and promotional literature
- Maintaining regulatory files to ensure the company’s compliance with regulatory requirements
- Implementing initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth without adversely impacting quality or regulatory compliance
- 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
- Collaborating with Operations to define and implement systems that enhance efficiency, productivity, and quality
- Collaborating with Clinical Affairs, Product Development, Quality, Marketing and Operations to drive best practices into project and fulfil design control activities and other Product Development Projects / New Products deliverables in a timely manner
- Ensure local regulatory requirements are met prior to distribution
- Develop and maintain strong, positive business relationships with key internal customers but also with external stakeholders
- Collaborate with regulatory representative(s) of international Distributors and/or Affiliates to ensure continued compliance with national regulations
- Track and develop internal / external trends and report on performance and effect on business to Management
- Work closely with Quality (and Clinical, as necessary) during audits/inspections
- Collaborate and coordinate projects while guiding/training internal customers on regulatory requirements
- International travel app. 25 %
**Requirements**:
- A minimum of a bachelor’s 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 3 (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 fulfil such requirements
- 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
- Good team player with strong interpersonal skills, also pragmatic and result-oriented
- Appropriate written / verbal communication skills in English, any other relevant language is a plus
- Familiarity with medical industry terminology
- Proficient in MS Office including Word, Power Point, and Excel
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._
- Our selection process is driven by the key_
- demands/requirements_
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._
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