Post Market Surveillance & Vigilance Specialist (Regulatory Affairs| Medical Device) – Onsite job opportunity at Sartorius AG.

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DateMore Than 30 Days Ago bot
Sartorius AG Post Market Surveillance & Vigilance Specialist (Regulatory Affairs| Medical Device) – Onsite
Experience: General
Pattern: full-time
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loacation Royston York Way, United Kingdom
loacation Royston York W..........United Kingdom

Join our team in Royston as a Post Market Surveillance & Vigilance Specialist. We are looking for a Post Market Surveillance and Vigilance Specialist to support our Regulatory Affairs function at Sartorius. In this role, you will be responsible for Post Market Surveillance and Vigilance tasks for our BPS core product portfolio e.g.: separation technology, fluid management, process filters and bags and transfer sets etc. and ensure alignment with global regulatory and internal requirements. The team consists of 15 professionals and we are looking forward to shaping the future with you.   This position is available full-time on a permanent basis and is based on site at our Royston, Hertfordshire with some hybrid working possible. The site is a short walk from Royston train station, on the Cambridge to London route and close to the A505. Grow with us – Your Responsibilities   On a daily basis you will conduct and assist the PMS, PMCF, Vigilance and Recalls (FSCAs) processes according to our processes and documented procedures as process owner Coordinate PMS data gathering and prepare the PMS plans and reports (PSURs), including review and signoff of the documents Coordinate the outsourced PMCF activities and communicate with the external PMCF Service Provider Organise PMCF data gathering and internal document reviews for PMCF data and reports, including signoff of documents Drive the recall process by creating and maintaining appropriate procedures, records, organising meetings, creating decision trees, and evaluating potential recalls (FSCAs) and reportability of incidents and complaints as well as communicate these cases to authorities Responsible for internal and external audits to represent PMS, PMCF, Vigilance and Recalls (FSCAs) as part of process ownership Collaborate with R&D, Product Management, Quality Assurance, Sales and Marketing Departments to ensure global quality and regulatory compliance What will convince us  BSc or Master’s degree in Life Science, Biotechnology, Pharmaceuticals, Biochemistry or relevant disciplines Experience in regulatory affairs with a focus on post market surveillance and vigilance in medical device, pharmaceutical or biotechnology industry Knowledge of regulatory requirements for medical devices and electronic data/quality management systems Ability to manage data, quality documents, trend analysis and translate data/information into reports to be used in a compliant and effective manner e.g.: within ISO9001, ISO13485, GxP and other similar quality systems Understanding and ability to apply quality and regulatory guidelines and regulations related to medical devices or products related to biotechnology and pharmaceutical industry Ability to develop innovative strategies and creative solutions within a regulatory context Strong analytical and problem-solving skills paired with a proactive approach Attention to detail with the ability to assess risks appropriately Excellent communication skills, with the ability to influence and negotiate a successful outcome under global matrix environment   In order to commence working with us, the successful candidate must have the right to work in the UK. What we offer  As a growing global life science company, stock listed on the German TecDAX, Sartorius offers a wide range of benefits:  Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings Making an impact right from the start: Comprehensive onboarding, including a virtual online platform  –  even before joining Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen network Health & Well-Being : Wide section of health and well-being support such as healthcare plans and health assessment services   Benefits Attractive Working Conditions: 37.5 hours working week 25 days annual leave, plus public holidays Free parking on site Annual option to buy, sell or carry forward annual leave Free hot and cold drinks Regular social events and free exercise classes Competitive benefits package, including: Group Personal Pension Plan Private Medical Insurance Private Dental Insurance Group Life Assurance Group Income Protection Cycle to work scheme About Sartorius  Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.  We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.  www.sartorius.com/careers

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