Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support regulatory affairs by managing post market surveillance and vigilance for medical devices.
- Company: Join Sartorius, a global leader in life sciences dedicated to advancing healthcare.
- Benefits: Enjoy competitive pay, health plans, and a supportive work culture with flexible hours.
- Why this job: Make a real impact in healthcare while developing your career in a dynamic environment.
- Qualifications: Degree in Life Science or related field; experience in regulatory affairs preferred.
- Other info: Collaborative team atmosphere with opportunities for personal and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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.
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
- 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.
Post Market Surveillance & Vigilance Specialist (Regulatory Affairs| Medical Device) – Onsite employer: Sartorius
Contact Detail:
Sartorius Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Post Market Surveillance & Vigilance Specialist (Regulatory Affairs| Medical Device) – Onsite
✨Tip Number 1
Network like a pro! Reach out to current employees at Sartorius on LinkedIn or other platforms. Ask them about their experiences and any tips they might have for landing the Post Market Surveillance & Vigilance Specialist role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of regulatory affairs and post-market surveillance. Be ready to discuss how your skills align with the responsibilities listed in the job description.
✨Tip Number 3
Showcase your problem-solving skills during the interview. Think of examples from your past experiences where you successfully navigated challenges in regulatory compliance or data management.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Sartorius.
We think you need these skills to ace Post Market Surveillance & Vigilance Specialist (Regulatory Affairs| Medical Device) – Onsite
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Post Market Surveillance & Vigilance Specialist role. Highlight relevant experience in regulatory affairs and any specific projects that align with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Use it to showcase your passion for life sciences and how your skills can contribute to our team at Sartorius.
Showcase Your Analytical Skills: Since this role requires strong analytical abilities, be sure to include examples of how you've successfully managed data or conducted trend analysis in your previous roles. We want to see your problem-solving skills in action!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Sartorius
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory requirements for medical devices, especially those related to post market surveillance and vigilance. Being able to discuss specific regulations like ISO 9001 or ISO 13485 will show that you're not just familiar with the field but also serious about compliance.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific situations, such as a potential recall or an audit. Think of examples from your past experience where you successfully navigated similar challenges. This will demonstrate your problem-solving skills and proactive approach.
✨Show Off Your Data Skills
Since the role involves managing data and preparing reports, be ready to talk about your experience with data analysis and quality management systems. Bring examples of how you've translated complex data into actionable insights in previous roles.
✨Communicate Effectively
Strong communication skills are key in this role, especially when collaborating with various departments. Practice articulating your thoughts clearly and confidently, and think about how you can influence and negotiate outcomes in a global matrix environment.
