As a Regulatory Services business stream Client Manager(Auditor) youll be responsible for frequently travelling and having overnight stays across the South Korea. Youll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. Youll also have the opportunity for occasional international travel to the USA and Europe. Youll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation). About BSI and the Regulatory Services Team: BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets. Key responsibilities accountabilities: Undertake management system assessments in accordance with BSI requirements. Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate. Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame. Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio. Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met. Plan/schedule workloads to make best use of own time and maximise revenue-earning activity. Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients business/technology and assist in the induction and coaching of new colleagues as requested. Maintain and develop assessment skills and technical and management system standards knowledge. Provide technical support to clients through business development, sales and customer service staff Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and Make Excellence a Habit . Candidate specifications Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation * Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper) Commercial understanding of compliance industry, minimum 2 years quality system management Knowledge of business processes and application of quality management standards Good verbal and written communication skills and an eye for detail Be self motivated, flexible, and have excellent time management/planning skills Can work under pressure Willing to travel on business intensively (80% ) An enthusiastic and committed team player Good public speaking and business development skill will be considered advantageous Key performance indicators: Delivery of man-days as booked in time and good quality work together with positive feedback from clients Feedback efficiently to both clients and internal queries Timely submission of reports Actively solve problems when needed with can do attitude Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them Make excellence a habit Help to avoid customer attrition by providing quality value added service and technical support Local hire.

Great that youre thinking about a career with BSI! Job title: GQA Certification Lead Location: India Homebased About the role This exciting role is to provide medical device quality management system leadership to QMS audit teams globally. The role comprises of four main elements: Manage the local ISO13485 scheme within ISO 17021, BSI, local, EA and IAF and other applicable accreditation requirements, as well as related regulated schemes (e.g. UKCA/CE). Support of the MDSAP and ISO 13485 certification-based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as UKCA and CE. Providing policy, input and expertise on medical device QMS audits within existing and developing certification schemes. The fourth element will comprise of leading improvement projects. The position will report to the GQA Technical Manager - Medical Devices and is home based. Responsibilities: Provide support of the MDSAP, ISO 13485 certification and CE/UKCA schemes, by for example, updating procedures, investigating regulator/accreditor non-conformities and customer appeals and supporting activities during witnessed or office regulator/accreditor audits. Leading smaller improvement projects and participating in larger projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement. Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI requirements for medical devices. Drive the output and quality of QMS audits globally via training development and delivery and report reviewing. Travel is expected to support training delivery, attendance at regulator/accreditor audits and for individual training requirements. Typically, this should constitute no more than 20% of your time, although this may initially be higher during the initial learning phase of the job role. The candidate should hold and maintain a valid passport. To be successful in the role, you will have: Bachelor s degree in engineering, science or related discipline. Minimum of two years of hands-on manufacturing experience plus two years quality management experience. Experience of coordinating or conducting audits of medical device manufacturers or certification bodies to ISO13485 (e.g. accreditation, supplier or internal audits). A comprehensive understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements). A good understanding of product and QMS certification concepts and principles. A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements. Broad technical understanding of medical devices and their manufacture. Excellent written and verbal communication, an excellent standard of English is a pre-requisite for the role. BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 20-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, meal allowance, paid maternity leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle. Do you believe the world deserves excellence? We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in. Headquartered in London, BSI is the worlds first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we re truly impartial, and home to the ultimate mark of trust, the Kitemark. Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company. If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family! D&I Policy BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive. If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner. Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.