Regulatory Affairs Manager
Location
Welwyn Garden City, Hertfordshire | United Kingdom
Job description
Regulatory Affairs Manager
Location : Remote
Job Type : Full time, 40 hours per week
Contract Type : Permanent
Salary : £50,000 - £60,000 per annum depending on skills & experience
Benefits : Private healthcare, income protection, life assurance, company pension scheme & 27 days holiday
Closing date : 01-04-2024
Amber Therapeutics are looking for an experienced Regulatory Affairs Manager to make a real impact on patients’ lives as we develop a closed-loop neuromodulation therapy to treat mixed urinary incontinence. We currently have locations in Bristol, Welwyn Garden City & London and therefore this role could either be based remotely with regular travel to sites or at one of the current company locations.
The Role An exciting new role within our growing team, you will manage regulatory affairs activities within the company. Working with the Engineering and Quality teams you will ensure that design control activities and product development are conducted in a suitable manner to ensure the company meets FDA and EU MDR requirements. You will be responsible for compiling regulatory submissions for new products to both EU Notified Bodies and US FDA.
Key Responsibilities: • Prepare regulatory submissions for the US FDA and EU Notified Bodies/Competent Authorities in line with European Medical Device Regulation
• Create & manage submission dossiers for new devices registrations and certificate renewals.
• Create and maintain STED, CER & regulatory files.
• Support the management of the QMS in line with ISO13485, CFR 820 and EU Medical Device Regulations
• Liaise with regulatory bodies & authorities (Competent Authority, Notified Bodies, FDA etc)
• Collaborate with R&D, Manufacturing and Quality departments as required.
• Review design/process/sterilisation validation documentation, preclinical/clinical documentation and ensure compliance to relevant ISO standards.
• Participate in the risk management process to meet ISO 14971 requirements.
• Interpretation and communication of new and changing Medical Device Regulations, creating appropriate actionable plans.
• Participate in the CAPA process (root cause investigations and corrective actions)
• Participate in the manage vigilance and complaints process.
• Responsible for product labelling and UDI requirements
• Responsible for management of EU Authorised Representative
• Company PRRC (note this role is split with the Quality Manager)
• Support design control and validation of new products & equipment.
• Technical support for regulatory impact upon change control process, production procedures, equipment changes and DMR/DHF documentation
Essential Skills & Experience • Previous regulatory experience within the medical device sector
• Experience of regulatory submissions to FDA including 510k and PMA submissions
• Experience of regulatory submissions to Notified Bodies for CE marking of medical devices.
• Knowledge of EU MDR
• Experience of working within ISO 13485, CFR 820 & GMP environments
• Risk Management and FMEA experience.
• With previous regulatory experience within a medical device company, the successful candidate should have good organisational skills with excellent attention to detail. A proactive self-starter, you will have strong interpersonal and communication skills, and thrive in a fast-paced, multi-disciplinary environment.
About Us Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber’s approach leverages the intelligent capability of its next-generation neuromodulation platform, the Picostim-DyNeuMo, to create ‘synthetic reflex arcs’ that can sense, interpret, adapt, and respond to a patient’s individual signals thereby restoring normal physiological function. This principle can be used in broader functional disorders of the nervous system that the Company’s academic partnerships are exploring.
What We Offer This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial.
We look forward to hearing from you!
You may also have experience in the following: Regulatory Compliance officer, Medical Devices Quality Assurance Engineer, Regulatory Affairs Officer, Quality Engineer, etc
REF-212 274
Job tags
Salary
£50k - £60k per annum
