Clinical Safety and Regulatory Compliance Manager

1 day left

Morgan Jones
21 Jun 2019
19 Jul 2019
Contract Type
Full Time
GBP100,000 - GBP135,000 DOE
Benefits Package
Our client, a national medical device specialist, is looking for a Clinical Safety and Regulatory Compliance Manager EU/UK to join them.
This role is responsible for managing all clinical safety activities for a Global Clinical program.
This will include reporting safety events in the EU/UK, communicating with EU/UK regulatory authorities and providing regulatory document support to notified bodies.
Working closely with the Global Clinical and Regulatory team (Headquartered in USA) this role reports directly to the VP.
Overview of Duties & responsibilities:
  • Support timely submission of all clinical regulatory documents to ethics committees and regulatory authorities as required.
  • Contribute to the development of a global safety database.
  • Collaborate with Study Managers and Clinical Research Associates to ensure comprehensive safety information is available and translated for full review, coding and reporting.
  • Ensure timely reporting in compliance with MEDDEV regulatory guidance documents.
  • Collaborate with the Global Clinical Safety team on the coding of adverse events in an electronic database system with query generation as needed; and query reconciliation through partnering with the Clinical Affairs team and the study sites.
  • Assist with new clinical study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
  • Evaluate clinical data and contribute to annual, interim and final reports of clinical information.
  • Minimum of a Bachelors' degree, health related or other scientific discipline; Advanced degree (MD, DVM) preferred.
  • Minimum of 3-5 years cardiovascular industry and global clinical trial experience
  • Knowledge of clinical trial and regulatory process required, including FDA, ICH, MEDDEV Guidance and ISO Regulatory Processes.
  • Ability to work cross-functionally and across time zones.
  • Self-motivated with excellent time management skills.
  • Ability to demonstrate competence and credibility to build relationships of trust with DSMB, CEC, CROs, physicians, statisticians and research staff at clinical sites.
About Morgan Jones:

Morgan Jones Recruitment Consultants Limited acts as an employment agency for permanent recruitment and as an employment business for the supply of temporary workers. By applying for this job, you accept the Terms & Conditions, Privacy Policy and Data Protection and Information Security Policy which can be found on the Morgan Jones website.

Due to the high volume of applicants applying for all roles, we can only reply to candidates with the most relevant skills and experience. If you have not heard back from us within 48 hours of your application, please assume that you have been unsuccessful on this occasion.

To view other great opportunities, visit our website or follow Morgan Jones on your favourite social networks - Facebook, Twitter or LinkedIn.