At a Glance
- Tasks: Lead regulatory strategies and manage technical files for innovative medical devices.
- Company: Abbott, a global healthcare leader with over 130 years of experience.
- Benefits: Competitive salary, flexible benefits, private healthcare, and pension scheme.
- Other info: Join a diverse team and enjoy excellent career growth opportunities.
- Why this job: Make a real impact in healthcare by ensuring compliance and safety of life-saving products.
- Qualifications: Bachelor’s degree in a scientific field and experience in regulatory roles.
The predicted salary is between 50000 - 65000 £ per year.
Abbott is a global healthcare company with more than 130 years of history. The Witney centre of excellence develops and manufactures glucose‑monitoring electrodes and biosensors used by patients.
Location: United Kingdom – Witney, England
Core Job Responsibilities
- Formulate, develop and lead business‑critical regulatory strategies for the EMEAP region.
- Act as the regulatory subject‑matter expert in design control projects, assessing changes and managing roll‑out programmes for existing products and new launches.
- Become a technical expert in ADC devices and support interactions with EU Notified Bodies/UK Approved Bodies and competent authorities.
- Manage the creation and development of EU & UK technical files in accordance with MDR 2017/745, IVDR 2017/746 and applicable regulations.
- Provide coaching and mentoring to junior team members.
- Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.
Education
- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Chemistry, Life Sciences or Biology.
Minimum Experience Required
- Knowledge of MDR 2017/745 Regulations and ISO13485 is essential; knowledge of IVDR 2017/746 is preferred.
- Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
- Experience with technical‑file creation, maintenance and post‑market changes.
- Experience working with Notified Bodies or other regulatory authorities.
- Excellent written and oral communication skills to produce concise reports and documentation and to communicate with internal and external stakeholders.
Benefits
- Competitive salary and a benefits package that includes a defined‑contribution pension scheme, a share‑ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements.
An equal‑opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Senior Specialist Regulatory Affairs in Minster Lovell employer: Abbott Laboratories
Abbott is an exceptional employer, offering a dynamic work environment in Witney where innovation meets healthcare excellence. With a strong commitment to employee growth, Abbott provides comprehensive benefits including a competitive salary, private healthcare, and tailored flexible benefits, fostering a culture of diversity and inclusion. Join us to be part of a team that not only values your expertise but also invests in your professional development within the thriving medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist Regulatory Affairs in Minster Lovell
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Abbott Laboratories. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Abbott Laboratories.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Abbott Laboratories. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Abbott Laboratories is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Specialist Regulatory Affairs in Minster Lovell
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 Abbott Laboratories!
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 Abbott Laboratories that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Abbott Laboratories!
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 Abbott Laboratories, 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 Abbott Laboratories
✨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 Abbott Laboratories that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
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
Take some time to familiarise yourself with Abbott Laboratories’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
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.
