A leading multinational pharmaceutical, and medical devices company currently has an attractive job vacancy available for a Regulatory Affairs Assistant to be based in their office in Leeds, UK.
To support medical device product registration activities and product registration submissions throughout the world, in order that registrations are achieved in a timely manner in accordance with regulatory and company requirements
- Support CE marking activities by compiling and maintaining appropriate Summary of Technical Documentation (STeDs) dossiers.
- Work independently to prepare and manage renewal applications for CE Class III devices
- With minimal supervision, collate information on regulatory impact of change projects and prepare regulatory submissions for re-registration activities.
- With supervision, prepare and manage responses to questions from regulatory bodies.
- Work independently to support registration activities and regulatory submissions in international markets
- Liaise with external partners and cross-functional project teams to obtain information and documents for regulatory submissions
- Manage multiple priorities and use various information sources to obtain and cross-check large volumes of information with a high degree of accuracy.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Follow and promote Company, HS&E and Quality / Compliance procedures and standards to enable the site to achieve and maintain excellent results.
Qualifications And Experience:
- A good first degree in a relevant scientific discipline, or equivalent experience.
- Relevant experience in a highly regulated industry (e.g. medical devices or pharmaceuticals)
- Regulatory experience covering medical devices preferred
- Computer competency in Microsoft office software, data collection and general analysis tools.
- Excellent written and verbal communication skills.
- Excellent accuracy and attention to detail.
- Ability to work on multiple projects, both independently and in a team environment.
- Strong organizational and problem solving skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.