Hobson Prior are looking for a Regulatory Affairs Specialist to join a Research and Development team who focus on delivering innovative products that enable better patient results.
- Effectively manage regulatory activities and provide regulatory advice to support business objectives.
- Guide and coordinate regulatory approval for new products and changes to existing products by ensuring that dossiers are created where appropriate in line with local country requirements.
- Develop and implement regulatory strategies and plans.
- Establish and maintain good relationships with and represent the Regulatory Department to worldwide regulatory colleagues at DePuy Synthes companies, distributors and external regulatory bodies.
- Communicate with internal departments and worldwide company colleagues to provide regulatory direction, input, support and advice.
- Establish and sustain processes for maintenance of registrations.
- Be aware of progress and developments of worldwide regulatory requirements and address changes as appropriate.
- Deliver regulatory input for post market surveillance and vigilance activities, audits, nonconformance disposition, corrective and preventative actions, post market product changes and product literature approval.
- Strong knowledge and skills in MS Office
- Strong interpersonal and diplomatic skills
- Team work oriented, within a multi-functional and multi-national team
- Demonstrated exceptional both written and oral communication skills.
- Proven high analytical, planning and organizational skills.
- A minimum of 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering.
- In-depth knowledge of ISO 13485 and ISO 9001, QSR.
- Understanding with Technical Documentation structure according to STED is required.
- Knowledge of MDR/MDD requirements.
- MEDDEV guidance documents applicable to Medical Devices products and processes.
- An understanding of FDA requirements and registration requirements in further global markets would be an asset.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.