Are you a Regulatory Affairs Specialist looking for an exciting new opportunity? Do you want to work for a large Medical company that make a real difference in the world? Would you be interested in working in an environment where you are valued and offered progression? Are you looking to work in a state-of-the-art facility? If so this may be the opportunity that you have been searching for…
The responsibilities of the Regulatory Affairs Specialist will be as follows:
- Represent Regulatory Affairs on products lifecycle development teams to ensure that all regulatory requirements are met.
- Complete submissions to regulatory entities as needed and maintain a tracking system for documents sent to agencies & customers.
- Create/Maintain technical document as required according to customer specified requirements.
- Document regulatory strategy and impact assessments for new product introductions and changes to existing products
- Support the sites in the timely renewal of certificates, licenses and registrations
- Assist in creation and approval of product labelling, TDS & MSDS
- Maintain current knowledge of MDD, MDR, FDA
What you will need to do the job:
- Knowledge of Quality systems and manufacturing processes in the medical device industry
- Demonstrated experience interfacing with external Regulatory inspectors/auditors and customer auditors
- Strong Project Management, technical, analytical & problem solving skills.
- Strong regulatory affairs working knowledge and experience with quality systems regulations and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive (MDD), Medical Device Regulation (MDR and US FDA regulatory requirements.
- Experience with Class II devices mandatory, Class III desirable
The successful Regulatory Affairs Specialist will be offered the opportunity to join an Organisation that are having an extremely successful period in the industry and you will drive improvement across the facility. Therefore, if you are a Regulatory Affairs professional that is looking for a dynamic, fast-paced environment, who would thrive in an organisation that has a genuine appetite for continuous improvement please get in touch.