At a Glance
- Tasks: Support regulatory compliance for innovative diagnostic products and ensure accurate documentation.
- Company: Join a leading company in consumer diagnostics with a focus on innovation.
- Benefits: Enjoy hybrid working, competitive salary, bonus, and generous leave.
- Other info: Work in a beautiful setting with excellent transport links and a supportive culture.
- Why this job: Make a real impact in women's health with cutting-edge diagnostic technology.
- Qualifications: BSc in life sciences and knowledge of medical device regulations required.
Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter and Gamble (P&G) and Abbott, and our brand Clearblue is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.
We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team on a full-time, 12-month maternity cover contract. The role will be based at our Innovation Centre in Bedford, UK with option for hybrid working.
The Regulatory Affairs Specialist role provides technical support for the Regulatory Affairs Department, ensuring regulatory elements of international distribution of SPD products, and implementation of changes to products in production are fulfilled. This role supports validation of product claims on a market specific basis and makes sure up to date documentation is available for all marketed products. The role holder will perform regulatory reviews of complaints for reportability, and report as necessary.
We’re looking for someone who holds a minimum of BSc Degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices, and knowledge of international regulations for medical devices. Experience of working with Notified Bodies and Regulatory Agencies is also desirable, and an R&D background would be beneficial.
The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly.
We Can Offer You:
- Hybrid working.
- Annual discretionary bonus.
- 25 days paid annual leave plus bank holidays.
- Company pension scheme including competitive employer’s contribution.
- Private Medical Insurance package with additional medical cash plan scheme.
- Enhanced maternity and paternity pay.
- Company supported employee Health and Wellbeing programme.
- Life assurance.
- Free electrical car charging points.
- Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail).
If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help. We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.
Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products. Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.
Interested? Click apply and you will be redirected to our careers page to complete your application.
Regulatory Affairs Specialist in Cardington employer: Swiss Precision Diagnostics GmbH
At SPD (Swiss Precision Diagnostics), we pride ourselves on being a leading employer in the field of consumer diagnostics, particularly in reproductive health. Our Bedford location offers a beautiful parkland setting with excellent transport links, fostering a collaborative and innovative work culture where employees are encouraged to grow and develop their skills. With competitive salaries, generous benefits, and a commitment to employee wellbeing, we provide a rewarding environment for those looking to make a meaningful impact in their careers.
Contact Details:
Swiss Precision Diagnostics GmbH Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Cardington
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at SPD or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CE marking and international regulations. We want to see you confidently discuss how your background fits with the role of Regulatory Affairs Specialist.
✨Tip Number 3
Show off your communication skills! Practice explaining complex regulatory concepts in simple terms. This will demonstrate your ability to represent SPD professionally and clearly.
✨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 SPD.
We think you need these skills to ace Regulatory Affairs Specialist in Cardington
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your relevant experience in life sciences and any knowledge of CE marking requirements. We want to see how your background fits with what we do at SPD!
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 your skills can contribute to our team. Keep it concise but engaging – we love a good story!
Show Off Your Communication Skills:Since excellent written communication is key for this role, make sure your application is clear and free of errors. We appreciate candidates who can communicate complex information simply, so let that shine through in your writing!
Apply Through Our Website:Don’t forget to apply through our careers page! It’s the best way to ensure your application gets to us directly. Plus, you’ll find all the info you need about the role and our company there!
How to prepare for a job interview at Swiss Precision Diagnostics GmbH
✨Know Your Regulations
Make sure you brush up on CE marking requirements and international regulations for medical devices. Being able to discuss these topics confidently will show that you’re well-prepared and knowledgeable about the industry.
✨Showcase Your Communication Skills
Since excellent written and oral communication skills are essential for this role, practice explaining complex technical information in a clear and concise manner. You might even want to prepare a few examples of how you've successfully communicated regulatory information in the past.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities, especially regarding regulatory reviews and compliance issues. Think of specific situations where you’ve had to navigate challenges in regulatory affairs and be ready to discuss your approach.
✨Research the Company Culture
Familiarise yourself with Swiss Precision Diagnostics and their commitment to innovation and consumer needs. Understanding their values and how they align with your own can help you articulate why you’d be a great fit for the team.
