At a Glance
- Tasks: Lead regulatory strategies and oversee compliance for innovative medical products.
- Company: Join Hologic, a company dedicated to advancing women's health through innovation.
- Benefits: Make a real impact while enjoying career growth in a supportive environment.
- Other info: Collaborative culture with opportunities to mentor and develop your team.
- Why this job: Shape the future of healthcare and improve lives with your expertise.
- Qualifications: Experience in regulatory affairs within the medical device industry is essential.
The predicted salary is between 60000 - 80000 € per year.
At Endomag, a Hologic company, we are driven by a clear purpose: advancing health through innovative medical technologies that improve and save lives. We are seeking an experienced Senior Manager, Regulatory Affairs to lead the Regulatory function at our Cambridge site. In this leadership role, you will oversee regulatory activities across a portfolio of innovative and established products. You will guide regulatory strategy, lead a high‑performing team, and partner with global and cross‑functional stakeholders to support product development, market access, and regulatory compliance.
What To Expect:
- Lead the Regulatory Affairs function at the Cambridge site and provide direction to the local regulatory team.
- Develop and execute regulatory strategies for new product development and existing products, aligned with global regulatory requirements and company policies.
- Drive regulatory submissions including pre‑clinical submissions, clinical trial applications, and marketing authorizations to support timely approvals.
- Provide strategic regulatory guidance to cross‑functional teams and translate regulatory requirements into practical development plans.
- Partner with divisional and senior leadership to align regulatory priorities with business and product development goals.
- Build and maintain relationships with regulatory authorities and represent the company in submissions, audits, and regulatory discussions.
- Support New Product Development programs, ensuring regulatory considerations are integrated throughout the product lifecycle.
- Oversee regulatory compliance for marketed products and support lifecycle management activities.
- Ensure product development and design changes comply with FDA Quality System Regulation, ISO 13485, and other applicable standards.
- Support regulatory aspects of clinical studies required for regulatory approvals.
- Mentor and develop regulatory team members while managing regulatory priorities, timelines, and resources.
- Monitor regulatory developments and industry trends to inform regulatory strategy.
What We Expect:
- Degree in engineering or a scientific discipline; biomedical engineering preferred.
- Significant Regulatory Affairs experience within the medical device or similarly regulated industry.
- Proven success managing regulatory submissions and compliance for medical devices; experience with combination products is advantageous.
- Experience interacting with regulatory authorities and supporting approvals in the US and EU.
- Strong knowledge of FDA regulations (21 CFR), ISO 13485, EU MDD/MDR, and global medical device regulatory frameworks.
- Solid understanding of medical device Design Controls and Risk Management.
- Demonstrated leadership experience in a matrixed organization.
- Strong analytical, communication, and stakeholder management skills.
- Ability to manage multiple priorities in a fast‑paced, collaborative environment.
Why Join Hologic?
- Make a Difference: Impact millions of lives by ensuring the highest standards in women’s health.
- Grow Your Career: Thrive in a global, innovative, and supportive environment.
- Drive Change: Be part of a company that values your ideas, expertise, and leadership.
Ready to make your mark? Apply now to lead regulatory excellence at Hologic!
Senior Manager, Regulatory Affairs in Cambridge employer: Hologic
At Hologic, based in the vibrant city of Cambridge, we are committed to advancing health through innovative medical technologies that make a real difference in people's lives. As an employer, we offer a dynamic work culture that fosters collaboration and creativity, alongside ample opportunities for professional growth and development. Join us to be part of a mission-driven team where your expertise in regulatory affairs will not only shape the future of women's health but also allow you to thrive in a supportive and forward-thinking environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Affairs in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA regulations and ISO standards. Be ready to discuss how your experience aligns with the role, especially in managing regulatory submissions and compliance.
✨Tip Number 3
Showcase your leadership skills! Be prepared to share examples of how you've successfully led teams and projects in the past. Highlight your ability to manage multiple priorities in a fast-paced environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Manager, Regulatory Affairs in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Senior Manager, Regulatory Affairs role. Highlight your regulatory experience in the medical device industry and any leadership roles you've held.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about regulatory affairs and how your background makes you a perfect fit for our team. Be sure to mention your experience with FDA regulations and your ability to manage multiple priorities.
Showcase Your Achievements:When detailing your past roles, focus on quantifiable achievements. Did you lead a successful regulatory submission? Did you improve compliance processes? Numbers and specific examples can really make your application stand out.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Hologic
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of FDA regulations, ISO 13485, and EU MDD/MDR. Be ready to discuss how these regulations apply to the role and how you've navigated them in your past experiences.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully led teams, managed projects, and influenced cross-functional stakeholders in previous roles.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or compliance issues. Think through potential scenarios and have clear, structured responses that highlight your problem-solving skills.
✨Build Rapport with Interviewers
Remember, interviews are a two-way street! Engage with your interviewers by asking insightful questions about their regulatory strategies and team dynamics. This shows your interest and helps you assess if the company is the right fit for you.
