At a Glance
- Tasks: Lead regulatory activities for postmarket surveillance of innovative medical devices.
- Company: Join Biocomposites, a global leader in infection management products.
- Benefits: Competitive salary, company events, pension, and employee discounts.
- Other info: Dynamic team culture focused on innovation and collaboration.
- Why this job: Make a real impact on patient care while growing your career in regulatory affairs.
- Qualifications: Bachelor's in life science, 3+ years in medical devices regulatory, and strong analytical skills.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Biocomposites, Ltd. is an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year!
We are distinct in that our team of specialists is singularly focused on the development of innovative calcium compounds and all research, manufacture and distribution takes place at our headquarters in Keele, England. In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years. Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world.
Job Summary
To lead regulatory activities relating to all postmarket surveillance activities for current on market implantable devices and MDR transition of Biocomposites products.
Duties & Responsibilities
- Coordinate and facilitate the generation of post market data for post market requirements.
- Aid and support the vigilance reporting for all territories and maintaining vigilance reports.
- Aid and support in the risk management activities for implantable devices.
- Prepare and review postmarket surveillance reports, postmarket clinical follow up plans and reports and review trend data according to territory requirements.
- Review and internally create and assess data trending reports, PSURs and PMS plan and reports and other regulatory documents.
- Monitor and harbour surgeon relationships for clinical data and product feedback for post market activities.
- Maintain awareness and support colleagues regarding regulatory status of products in relevant countries.
- Provide general support for activities falling under the remit of the Regulatory Affairs Clinical Data Manager.
- Act as a mentor to junior regulatory staff members
- Provide Regulatory Affairs support during internal and external audits.>
- Liaise with regulatory authorities and Notified Bodies as required.
- Support and act as delegate for activities falling under the remit of the Regulatory Affairs clinical data Manager.
- Provide regulatory assistance for medical device regulatory transitions and submissions.
Required Experience
- Bachelor’s Degree in a life science or medical field.
- 3+ years experience within Medical Devices Regulatory or Quality
- Experience with post market surveillance and reporting.
- Ability to review and appraise disparate information into comprehensible reports.
- Experience of data analysis and report writing.
- In-depth knowledge of EU MDR.
- Organisational skills and an ability to work to tight timelines.
- Proficient in the use of Microsoft Office.
- Enthusiastic and eager to learn, motivated to develop a career within Regulatory/Medical Devices.
- Commutable to the office and able to work Monday to Friday, 8/9am-4/5pm onsite minimum 4 days perweek.
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
People we look for
People who are passionate about what we do.
People who are open minded to evolving the way we work.
People who can work together to transform outcomes and change lives.
Benefits
- Company events
- Company pension
- Employee discount
- Free or subsidised bus travel
- Free parking
Regulatory Affairs Postmarket Specialist in Keele employer: Biocomposites
Biocomposites, Ltd. is an exceptional employer located in Keele, Staffordshire, offering a dynamic work environment where innovation thrives. With a strong focus on employee growth and development, we provide competitive salaries, comprehensive benefits, and a culture that values teamwork and diverse perspectives. Join us in making a meaningful impact on patients' lives while enjoying unique perks such as free or subsidised bus travel and company events.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Postmarket Specialist in Keele
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet!
✨Tip Number 2
Prepare for interviews by researching Biocomposites and their products. Show us you’re genuinely interested in our mission and how your skills can contribute to our innovative work in infection management.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to postmarket surveillance and EU MDR. We want to see how you can apply your experience to real-world scenarios!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re keen to be part of our team!
We think you need these skills to ace Regulatory Affairs Postmarket Specialist in Keele
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Postmarket Specialist role. Highlight your experience in post market surveillance and any relevant projects you've worked on. We want to see how your skills align with what we do at Biocomposites!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission. Be sure to mention your enthusiasm for working with medical devices and your eagerness to learn.
Showcase Your Data Skills:Since this role involves a lot of data analysis and report writing, make sure to showcase your skills in these areas. Include specific examples of reports you've created or data trends you've analysed. We love numbers, so let them speak for you!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Biocomposites!
How to prepare for a job interview at Biocomposites
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU MDR and postmarket surveillance. Be ready to discuss specific examples from your experience that demonstrate your understanding of these regulations and how they apply to the role.
✨Showcase Your Data Skills
Since the job involves a lot of data analysis and report writing, prepare to talk about your experience in these areas. Bring examples of reports you've created or data trends you've analysed, and be ready to explain your thought process.
✨Demonstrate Team Spirit
Biocomposites values team spirit and engagement, so be prepared to discuss how you've worked collaboratively in the past. Share stories that highlight your ability to mentor others and support your colleagues in achieving common goals.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company's products, culture, and future plans. This shows your genuine interest in the role and helps you assess if it's the right fit for you. Plus, it gives you a chance to engage with your interviewers!
