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, and generous leave plus health benefits.
- Other info: Work in a beautiful setting with great transport links and career growth opportunities.
- Why this job: Make a real impact in women's health while working in a dynamic environment.
- Qualifications: BSc in life sciences and knowledge of medical device regulations required.
Salary: £30,000 – £35,000 DOE plus benefits
Location: Bedford
Full‑Time; 12‑month Fixed Term Contract
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 & 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 fixed term 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.
Qualifications
- Minimum of BSc Degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.)
- Comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices
- Knowledge of international regulations for medical devices
- Experience of working with Notified Bodies and Regulatory Agencies is desirable
- An R&D background would be beneficial
- Good interpersonal skills and excellent written and oral communication skills are essential
- Ability to communicate complex technical information clearly
Benefits
- 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.
Equal Opportunity
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.
The Company 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.
Regulatory Affairs Specialist in Bedford 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 Bedford
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We think you need these skills to ace Regulatory Affairs Specialist in Bedford
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Swiss Precision Diagnostics GmbH!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Swiss Precision Diagnostics GmbH that you're not just a fit for the job but also a safety-conscious candidate!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Swiss Precision Diagnostics GmbH, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Swiss Precision Diagnostics GmbH
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Swiss Precision Diagnostics GmbH that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
