Regulatory Affairs Specialist

Job DescriptionSinclair is Hiring! Join Our Team as a Regulatory Affairs Specialist We are currently recruiting for Regulatory Affairs Specialist in the UK. The Regulatory Affairs Specialist will be responsible for regulatory activities in support of lifecycle management for injectable medical device products at Sinclair. This Regulatory Affairs Specialist will support a variety of responsibilities and requirements within the company to achieve agreed targets and schedules to maintain/obtain new and current authorisations/registrations for injectable medical device products. The RA Specialist supports regional markets (EU/CEE) and is part of the RA team.The ideal candidate will have 3-5 years experience in Regulatory AffairsLocation: 3 days a week in either our Chester or London officeAbout SinclairFounded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.Sinclair Values: Act with Integrity Consistently doing the right thing even when its the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleaguesWhat You'll Be Doing:To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines, specifically for EU/CEE markets, for Sinclair products.Communicate to management any changes in regulations or requirements that have been identifiedUndertake the preparation and submission of all new regulatory applications (e.g. clinical trials, registrations, renewals, variations, labelling / artwork) to agreed timelinesEnsure all authorizations / registrations related to established products are maintainedMonitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectationsInteract with regulatory consultants, regulatory and trade associates and other third-party service providers to ensure their provision of any requested activities to agreed timescalesTo provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilitiesReview and approve product artworksMaintain all submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory informationIdentify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairsLiaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessaryMaintain monthly business reports as necessaryRaise purchase orders as necessary and manage invoices related to assigned work.Assist in maintenance of tracking spreadsheets of costs for budgeting purposes.Organise consular services and translation services.Provide technical / regulatory input to Change Control Regulatory Assessments (EU/CEE) and associated RCN / RFRI. Work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regionsYour skills and experienceEssential:University Degree in a scientific or engineering field, desirable but not essential.3-5 years experience in Regulatory AffairsGood in written and spoken English and regional languages as applicable.Knowledge of Regulatory legislation and guidelines for medical devices.Excellent computer and administration skills.Experience of working in an office environment and with both internal and external suppliers/customers.Desirable:Specific knowledge in dermatology/aestheticsWorking knowledge of Pharmaceutical and Biologic RegulationsPerformance-driven critical thinkerStrong business acumenAbility to coordinate and prioritize multiple demanding tasks in a fast-paced environment.Ability to work effectively in a team environment and build strong working relationshipsWhat We're Looking For:Well-organised, target-orientated and flexible.Ability to work under pressure to tight deadlines in a multidisciplinary environment.Ability to complete work with minimal supervision.Strong written and oral communication skills.Management of confidential information.Excellent attention to detail when reviewing and preparing documentation.Ability to support project teams and managementEstablish and maintain relationships with local affiliates and partnersOrientation towards achievementAdaptability and openness to changeAbility to mentor and learnIntegrity and professional ethicsCross-disciplinary cooperationPerks & Benefits:25 days annual leave (plus bank holidays)Company bonus schemeFree parking onsiteCompany pension schemePrivate medical insuranceHealthcare Cash planHealth ScreeningEmployee Assistance ProgrammeStore discountsTech and Cycle SchemeDiscounted dining cardCycle to work schemeGreen car schemeHoliday buy and sellLife Assurance schemeWe have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.This is an exciting opportunity to join a successful company, with big ambitions for the future.If this sounds like you and you meet the requirements, please apply, we would love to hear from you.Please note if we receive a high volume of applications, we may close the role before the closing date noted.By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad.Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void

Created: 2025-07-03