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.
- 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.
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 High Wycombe 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 High Wycombe
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Hologic.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Hologic.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Hologic, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Senior Regulatory Affairs Specialist in High Wycombe
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Hologic.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Hologic.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Hologic. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Hologic. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Hologic
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Hologic’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
