Regulatory Affairs Specialist / Senior

Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist

Salary: Up to £55,000 per year, depending on experience

Location: Camarthenshire, Wales, but can be Remote/Hybrid depending on your location

Company:

Working for a Med-tech company, a leader in neurotechnology solutions that revolutionises brain research and clinical practice. With cutting-edge tools like Electroencephalography (EEG), Transcranial Magnetic Stimulation (TMS), and Transcranial Direct Current Stimulation (tDCS), they empower researchers and clinicians to advance the understanding and treatment of brain disorders. Their innovative products enhance patient outcomes and drive scientific discoveries, making them the partner of choice for those at the forefront of neuroscience and mental health care.

Purpose:

Combine the knowledge of scientific, regulatory, and business issues to enable product development, manufacture, and life cycle maintenance to meet applicable regulatory requirements and technical standards.

Responsibilities:

• Provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices.
• Communicate to management any changes in regulations or requirements that have been identified.
• Work with in-country distributors or contractors where required.
• Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
• Interact with regulatory consultants, regulatory and trade associates, and other third-party service providers to ensure their provision of any requested activities to agreed timescales.
• Maintain all submission documents, shared drive folders, and databases accurately, completely, and timely to ensure prompt and accurate access to company regulatory information.
• Identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
• Identify improvements regarding work processes or operational plans and schedules in order to achieve department objectives and take the lead in projects where required.
• Prepare, submit, and maintain Technical Files in accordance with the EU Medical Device Regulation (2017/745).
• Monitor changes in Legislation, Standards, and Guidance Documents.
• Contribute to the development and implementation of regulatory policies, procedures, and specifications across the company, ensuring compliance with the Quality Management System.
• Perform other reasonable duties commensurate with the skills and responsibilities of the post holder.

Skills:

• Understand standards and regulations and how they apply to medical devices.
• Remain calm in high-pressure situations, e.g., during audits.
• Ability to assimilate information quickly.
• Attention to detail.
• Bachelor's degree in a Scientific or related field.
• Excellent interpersonal, teamwork, and verbal/written communication skills.

Experience required:

• Minimum 2-3 years in the medical device industry.
• Experience operating in an ISO 13485 and 21 CFR 820 certified Quality Management System.

Knowledge required:

• Medical Device Regulation (2017/745).
• ISO 13485 and 21 CFR 820, Quality Management Systems.
• MEDDEV 2.7/1, MEDDEV 2.12/2, 21 CFR 803.
• ISO 14971 (Risk Management of Medical Devices).

Apply or contact for an informal, confidential chat.