Our client is a privately owned, multi-disciplined engineering company based in the south area and currently seeking to recruit an experienced Regulatory Affairs Engineer to join their Regulatory / Compliance Department. The successful candidate will work within a close-knit, multi-disciplinary team of engineers.
The Regulatory Affairs Engineer will have a strong working knowledge of international and EU regulations and standards for electronic equipment.
Principal Responsibilities
*Prepare and maintain regulatory submissions for electronic products, including reviewing manufacturing processes.
*Collaborate with members of the scientific team to develop detailed plans for regulatory and supporting activities required for successful submission.
*Liaise with EU regulatory authorities and licensing partners, and draft regulatory strategy plans.
*Work with QA personnel on the preparation of packaging and labelling, including artwork.
*Participate in the preparation of SOPs and submission documentation, and recommend new approaches, policies, and procedures.
*Stay up to date with new policies and regulatory changes that may impact product registration status.
Education and Experience
A BEng in Electronics or a related discipline with significant experience in regulatory affairs, ideally within the medical device industry.
Skills and Attributes
*Excellent interpersonal and communication skills, both written and verbal.
*Strong problem-solving abilities, with the capacity to make sound recommendations aligned with industry standards, practices, and regulatory requirements.
*Ability to communicate effectively with clients and regulatory authorities.
*Strong organisational skills, with the ability to manage and prioritise workload effectively
Only candidates living in the UK with work authorisation will be considered.