Regulatory Affairs and Compliance Coordinator - Medical Devices -
A great career opportunity has arisen for a Regulatory Affairs and Compliance Coordinator to come and join an expanding client focused company that has a global presence within the Regulatory Affairs Industry. This is a fast growing, leading International healthcare and Medical Devices Company that adhere to high level of understanding and compliance processes within Medical technology along with preparing regulatory documentation, manufacturing and design ensuring full product quality is met when developing the company's business strategies.
Key responsibilities include:
* Support Regulatory Affairs Manager and provide regulatory input and data associated with compliance and achievement of business plan for UK and Internationally.
* Provide regulatory data for tenders and regulatory support to Sales and Marketing and Customer Services including updates on CE marking pending approvals.
* Manage pending requests for additional information on complaints, vigilance and field actions from Competent Authorities as needed.
* Control of internal Quality Management system audit schedule.
* Develop, manage and maintain good working relationships with Competent Authorities to ensure business is not adversely impacted. CAPA Plans
* Be responsible for recommending and implementing techniques to improve productivity, increase efficiencies, cut cost and maximise opportunities
Experience
The successful applicant will be educated to degree level and has good working knowledge of ISO 13485 standards. A minimum of 3 years Regulatory experience with the Medical Devices sector. They are looking for someone who will have a bright and personable disposition and be able to demonstrate excellent interpersonal skills. Have a good understanding of practical application of the Medical Device Directive.
He or she will also have the ability to work collaboratively with colleagues and seek to positively influence individuals at all levels of the business, therefore the applicant must possess good motivational skills with the ability to develop technical new skills.
If successful, you will be rewarded with a completive salary, excellent benefits package, including healthcare and a company pension scheme. If you want to be a part of this exciting, challenging opportunity, please contact Ekta Multani, Medical Devices Recruitment Specialist at Paramount Recruitment, on 0121 616 3474.
Keyword: Regulatory Affairs Associate , Regulatory Affairs Coordinator, Design Control , Compliance , Quality Assurance , Regulatory Affairs, Medical Devices , ISO 13485, FDA, 21 CFR Part 820, research, Design Compliance , CE Marking, SOPS, Gloucester
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