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 a pension scheme.
- Other info: Join a diverse team and enjoy excellent career development opportunities.
- Why this job: Make a real impact in healthcare by ensuring compliance and quality in life-saving products.
- Qualifications: Bachelor’s degree in a scientific field and experience in regulatory roles.
The predicted salary is between 55000 - 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 employer: Abbott Laboratories
Abbott is an exceptional employer, offering a dynamic work environment in Witney, where innovation meets healthcare excellence. Employees benefit from a competitive salary and a comprehensive benefits package, including private healthcare and a flexible benefits scheme tailored to individual needs. With a strong commitment to diversity and opportunities for professional growth through coaching and mentoring, Abbott fosters a culture of collaboration and continuous improvement, making it an ideal place for those seeking meaningful and rewarding careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist Regulatory Affairs
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Abbott Laboratories looking for candidates who are engaged and informed.
We think you need these skills to ace Senior Specialist Regulatory Affairs
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Abbott Laboratories. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Abbott Laboratories
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Abbott Laboratories’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
