Senior Regulatory Affairs Expert
In this challenging role you will be responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide.
- Prepare, coordinate and execute regulatory submission with: FDA /European Notified Bodies/Health Canada/Any other territories as appropriate
- Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentatio
- Review analytical data from development studies, performance evaluation studies, and clinical field trials to ensure regulatory requirements are met.
- Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
- Advise the compagny staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
- Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications worldwide
- Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
- Providing support, guidance and training as needed to fellow team members to ensure maintenance of world class regulatory team.
- Contribute to the design and implementation of regulatory processes and identify areas for potential improvement.
- Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance and industry standards
- Assist with the implementation of the Company’s Quality Policy
QUALIFICATIONS AND EXPERIENCE REQUIRED
- Scientific degree with a minimum of 5 years of experience in regulatory within the Lifescience Industry
- Previous experience in bringing a new product to market, significant experience of Design Control or Development project
- Previous filing experience in EU and USA: BLA, PMA, 510(k), high class CE marking submission
- Significant specialist knowledge of regulation as it applies to Medical Devices, Drugs or Biologics as well as related industry standards
- Ability to interface with regulatory authority
- Good technical writing skills and ability to negotiate/convince