Regulatory Affairs Specialist

Job DescriptionRegulatory Affairs SpecialistCompetitive Salary + Superb BenefitsHours: Monday to Friday 9am – 5pmCARDIFFPlease note; Regulatory Affairs experience within the Medical Device Industry is essentialThe Company:Our client is a market leader in their field. They manufacture and supply a range of products to healthcare providers across the UK and internationally. You would be joining a business that is experiencing an exciting, sustained period of growth. They are an employer who genuinely value their staff and have an impressive benefits package, and great working environment.The Job:This is a senior role and requires the RA Specialist to provide sole responsibility and leadership on regulatory affairs, supporting NPD project, maintain compliance of products, support audits, owning risk management file and CER, developing and implementing RA strategy, product surveillance, preparation of tech file, submission of regulatory applications and communications with international regulatory approvals. Be part of the NPD team, reviewing and approving documents, involve in design and stage gate reviews. Surveillance of new standards and ensuring NPD meets recognise consensus standards, etc. Involve in CAPA team to resolve issues.Qualifications required: BEng/BSc in Engineering or Science or related field with RA experience within the medical device industry. BEng/BSc in mechanical/medical/biomedical/materials engineering is an advantage.Experience required: At least 4 years RA experience in Class 1 medical device as essential (Class 2 will be desired) for major territories FDA, UKCA and MDR is essential.Additional knowledge for Canada, Australia, Japan registration will be desired.Design and implement QMS for design control, be part of NPD team and remediation activities to prepare and maintain tech files to ensure continuous compliance.Good knowledge of ISO13485 and ISO14791 and maintenance of RMF.Timely preparation of submissions and communication with regulatory organisations such as Q-sub and eSTAR with FDA, etc.Develop and implement regulatory strategy for NPD and existing products to maintain compliance.Essential skills: Able to lead RA activities and be the first point of contact for compliance enquiries.Good communication skills and can effectively communicate with regulatory, legal, R&D, sustaining engineering, sales and operations.Able to work with NPD teams.Able to manage day-to-day activities and tasks, and work independently in RA mattersDesirable skills / experience: Class 2A/B medical device experienceGood regulatory application knowledge on other territories in addition to FDA/UKCA/MDRClinical knowledge in tissue viabilityThe Person:“Can do” attitude; A “finisher” and drive to complete projects, with a track record of products from start to launch. Honesty and integrity, dependability and reliability, flexibility and willingness to work collaboratively along with emotional intelligence and creativity.Superb Benefits: Defined contribution pension scheme (matched employer contribution of 5%), Perkbox membership, plus 50 flexi points per month (worth £5), Paid rest breaks (average 50 minutes per day over 5 days) pro rata, Discounts at local gym, Free on-site parking, Company workwear available free of charge (but not mandatory), Free mortgage advice through our Mercer Marsh partners, Holidays 25 days annual leave plus public holidays, Defined shut down period between Christmas & New Year, Cashplan (Medicash) with access to GP, support services and annual capped amounts towards healthcare, Employee Assistance Programme (Health Assured) for employee and immediate family, Funded company social events (at least twice a year), Large, well equipped comfortable rest area (Copa) with free access to hot & cold drinks, bread for toast and other condiments, Secure outside rest area, onsite electric charging (nominal fee) car sharing incentives and more….