The Quality and Regulatory team at DB Orthodontics Ltd is looking for a Fulltime/Permanent Regulatory Specialist to support the business in all duties necessary for us to remain in compliance with ISO 13485, Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745 (EU MDR).
As a Senior Regulatory Associate, your primary responsibilities will include:
1. Reviewing, updating and creating technical files and completing Post Market Surveillance activities, Risk Management plans and reports, Clinical Evaluation Reports covering a range of Class I and IIa medical devices.
2. Responding to internal and external regulatory queries.
3. Completing Internal Audits.
4. Providing support to the Regulatory Manager and Quality and Regulatory Consultant.
As the Senior Regulatory Associate, you will need to have the following experience and skills:
1. Regulatory Affairs experience within medical devices; preferably from a commercial environment (5 years minimum).
2. Good knowledge of MDD and MDR.
3. Good knowledge of ISO 13485.
4. Analytical and problem-solving skills.
5. Written and oral communication skills with a high level of attention to detail.
6. Ability to multitask and prioritize.
7. Integrity and a professional approach to work.
A technical background would be an advantage.
If you wish to be considered for this exciting opportunity within a progressive and growing business, please apply today by email to Human Resources directly at humanresources@dbortho.com with an introduction letter and CV, and we will issue you thereafter with the job application form for completion.
Position Sought: Senior Regulatory Associate - Medical Devices
Employment Type: Full time, permanent
Contracted Hours: Monday to Friday working a 37.5 hours week
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