Senior/Regulatory Affairs Officer
Oliver Care at CK Clinical is recruiting for a Senior/Regulatory Affairs Officer to join a company in the Medical Device industry at their site based in Midlothian on a permanent basis.
The main purpose of the role will be to
- Prepare, submit and maintain product licence/registrations with the FDA, European notified bodies, Health Canada and any other territories as appropriate. You may also compile product information for the preparation of technical files and regulatory dossiers to support licence applications and maintenance.
- Be responsible for developing and maintaining product labelling requirements and liaise with external suppliers to provide new and revisions of labelling artwork
- Liaise with Regulatory authorities and external customers/vendors/distributors to provide information to support Regulatory processes and compliance issues. You may also advise staff and team members of data and information required for successful license applications and Manage direct reports by providing support and guidance as needed.
Further responsibilities will include:
- Ensuring the accurate recording and completion of all departmental documentation including revisions through a change control process
- Conducting all duties in compliance with cGMP, ISO 13485, ISO 9001, GCP and Regulatory requirements and assisting with the implementation of the Company's Quality Police to ensure compliance with these.
- Contributing to the design and implementation of new quality systems and procedure identifying areas for potential improvement and scheduling routine work within the department to maximise the use of available resources.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A relevant degree and work experience in a cGMP environment.
- Appropriate experience within Regulatory Affairs in the manufacture of IVD diagnostic devices, biologics or medical device instrumentation and previous experience of filing BLA, PMA and 510(K) submissions.
- Experience of preparing submissions and excellent communication and organisation skills. Previous management experience or strong leadership skills would be required for the senior role.
This is an excellent opportunity to join a global medical device company focused on providing high quality immunohaematology products for use in transfusion diagnostics
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30722 in all correspondence.