At a Glance
- Tasks: Support regulatory submissions and ensure compliance for innovative medical devices.
- Company: Join Hologic, a leader in health innovation and regulatory excellence.
- Benefits: Competitive salary, comprehensive training, and a supportive work environment.
- Other info: Dynamic role with opportunities for career growth and cross-functional collaboration.
- Why this job: Make a real impact on global health by ensuring product compliance and safety.
- Qualifications: Experience in regulatory affairs and strong understanding of international regulations.
The predicted salary is between 40000 - 50000 £ per year.
At Hologic, we are committed to enabling healthier lives everywhere, every day. To deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations.
We are looking for a Senior Regulatory Affairs Specialist to support regulatory submissions, audits, inspections, technical documentation, and product lifecycle activities for medical devices. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.
What to expect:
- Prepare, coordinate, and compile document packages for regulatory submissions, audits, inspections, license renewals, and annual registrations.
- Support regulatory activities for new and mature medical device products, including product changes and ongoing compliance.
- Manage and maintain regulatory databases, technical files, and supporting documentation.
- Review technical data, reports, labeling, marketing materials, user manuals, and other product content for regulatory compliance.
- Support compliance with US, EU, Canadian, and international regulatory requirements.
- Manage labeling and unique device identification requirements.
- Provide regulatory input on design reviews, manufacturing changes, clinical protocols, and product approval strategies.
- Document regulatory decisions and ensure documentation remains current, accurate, and inspection-ready.
- Participate in internal and external audits, inspections, and investigations.
- Monitor evolving regulations, standards, and procedures, and translate changes into practical business guidance.
- Contribute to process, procedure, standard, and tracking/control system improvements.
- Partner with cross-functional teams to resolve regulatory issues and support timely product approvals.
What we expect:
- Experience in the regulated medical device industry, ideally supporting product lifecycle and regulatory compliance activities.
- Hands-on experience with regulatory submissions, technical files, product documentation, audits, inspections, and investigations.
- Strong understanding of US FDA, EU, Canadian, ISO 13485, ISO 9001, and other applicable international regulatory requirements.
- Ability to review labeling, marketing materials, user manuals, technical documentation, and supporting data from a regulatory perspective.
- Strong technical writing, communication, interpersonal, and presentation skills.
- Good data and statistical analysis skills, with the ability to make informed recommendations.
- High attention to detail and strong judgment when evaluating regulatory issues and solutions.
- Confidence working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and global partners.
- Proficiency with Microsoft Office and confidence working with regulatory databases or tracking systems.
- A college degree or technical bachelor’s degree, preferably in a scientific, engineering, or related discipline.
- Regulatory Affairs Certification — RAC — or project management experience would be beneficial.
Why join Hologic?
At Hologic, your work has purpose. You will be part of a company focused on improving health through innovation, quality, and regulatory excellence. We are committed to making Hologic a destination for top talent. From the moment you join, we provide comprehensive training, ongoing development, and the tools and knowledge you need to succeed and grow your career.
If you are a regulatory affairs professional who enjoys technical documentation, submissions, cross-functional partnership, and supporting products throughout their lifecycle, we would welcome your application. Apply today and help us enable healthier lives everywhere, every day.
Salary: £40,000 – £50,000 gross per year. The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.
Senior Regulatory Affairs Specialist in Liverpool employer: Hologic
Hologic, Inc. is an exceptional employer that prioritises innovation and employee development within the healthcare sector. With a strong focus on advancing women's health, employees are encouraged to grow their skills in a collaborative environment while making a meaningful impact in the lives of patients. The Central North territory offers a dynamic market landscape, providing unique opportunities for sales specialists to thrive and build lasting relationships with healthcare professionals.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Liverpool
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Hologic. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
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 Hologic.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Hologic. 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 Hologic is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Liverpool
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 Hologic!
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 Hologic 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 Hologic!
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 Hologic, 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 Hologic
✨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 Hologic 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 Hologic’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.
