Senior Regulatory Affairs Specalist

A unique opportunity has arisen for a Senior Regulatory Affairs Specialist to join an innovative medical device company. The Company is well established within its area of expertise, recently undertaking a well-funded expansion increasing their development and manufacturing capacity. The successful candidate will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations, as well as supporting the organization's global expansion.

Responsibilities:

- Provide support for registration activity this includes, developing registration and launch plans, establish and maintain regulatory information systems and implement new regulatory requirements

- Guarantee compliance to global regulatory requirements and company policies

- Provide contribution to company activities including risk management processes, process and procedure improvements, management review and support new product development

- Review document and product changes for regulatory submission impact

- Support equipment system and process development in-house and with external suppliers

- Liaise and co-ordinate with regulatory agencies; deliver regulatory input and appropriate follow-up support to inspections and audits

Participate on product development teams to ensure regulatory requirements are incorporated into the development process

Experience:

- 3-5 year's experience in a regulatory role within the medical device industry

- Either

           - A degree in a science, clinical or engineering subjects

           - 2-5 years equivalent experience achieved through a medical device                             environment

- Experience in the requirement of Quality system concepts, practices and procedures (Specifically ISO 13485)

- Exceptional attention to detail, highly ambitious and decisive individual

I work on a range of interesting Scientific focused positions that are available within the pharmaceutical industry. I can provide career advice whether you are looking or not, please reach out to me on 01293 776644.