At a Glance
- Tasks: Lead regulatory strategies and oversee compliance for innovative medical devices.
- Company: Join Hologic, a leader in advancing women's health through technology.
- Benefits: Impactful work, career growth, and a supportive global environment.
- Other info: Collaborative culture with opportunities to mentor and develop your team.
- Why this job: Make a difference in healthcare while driving regulatory excellence.
- 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: Job Search Place Limited
At Hologic, we are committed to advancing health through innovative medical technologies, making us an exceptional employer for those passionate about impactful work. Our Cambridge site fosters a collaborative and supportive culture, offering ample opportunities for professional growth and development while ensuring that your contributions directly enhance women's health globally. Join us to lead regulatory excellence in a dynamic environment where your expertise is valued and your career can thrive.
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. We recommend practising common interview questions related to regulatory strategy and compliance to showcase your expertise.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've successfully managed teams and projects in the past. Highlighting your ability to guide cross-functional teams will set you apart from other candidates.
✨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 genuinely interested in joining our mission to advance health through innovative technologies.
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 is tailored to the Senior Manager, Regulatory Affairs role. Highlight your relevant experience in regulatory submissions and compliance, especially within the medical device industry. We want to see how your background aligns with our mission at Hologic!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about advancing health through innovative technologies. Share specific examples of how you've led regulatory teams or managed submissions that resulted in successful product approvals.
Showcase Your Leadership Skills:In this role, you'll be leading a team, so make sure to highlight your leadership experience. Talk about how you've mentored team members or driven regulatory strategies in previous positions. We love seeing candidates who can inspire and guide others!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, it shows us you’re serious about joining our team at Hologic!
How to prepare for a job interview at Job Search Place Limited
✨Know Your Regulations
Make sure you brush up on the latest FDA regulations, ISO 13485, and EU MDD/MDR guidelines. Being able to discuss these in detail will show that you're not just familiar with the rules but can also apply them strategically in your role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in a regulatory environment. Highlight specific instances where your leadership made a difference in project outcomes or team performance, as this role requires strong management capabilities.
✨Understand the Product Lifecycle
Familiarise yourself with the entire product lifecycle in the medical device industry. Be ready to discuss how regulatory considerations fit into each stage, from development to market access, and how you can integrate these into practical plans.
✨Build Relationships
Think about how you've built relationships with regulatory authorities in the past. Be prepared to share strategies for effective communication and collaboration, as this role involves representing the company in submissions and audits.
