At a Glance
- Tasks: Lead regulatory projects and manage medical device submissions for the US and UK/EU.
- Company: Join CooperSurgical, a leader in fertility and women's healthcare.
- Benefits: Remote work, competitive salary, and a supportive team environment.
- Other info: Dynamic role with opportunities for professional growth and collaboration.
- Why this job: Make a real impact on women's health and family care with innovative solutions.
- Qualifications: Master’s degree in relevant field and 4+ years in regulatory affairs.
The predicted salary is between 50000 - 65000 £ per year.
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.
At CooperSurgical we are currently looking to recruit a Senior Regulatory Affairs Specialist. You will be part of the global regulatory team with 20 international colleagues. The position is remote but based out of the UK. The Sr. RA specialist will be reporting to the RA manager also working out of the UK.
In the role of Sr. RA specialist, you will be responsible for regulatory activities such as registration documentation and product applications and renewals to local authorities primarily focusing on FDA 510(K) and UK/EU MDR. You will identify and maintain documentation including updates and review of the technical files for the IVF devices product portfolio and support the MDR filling (class I, IIa). You will maintain the regulatory QP/QI’s in the quality management system in cooperation with your fellow peers in regulatory affairs. As a person, you thrive in a dynamic and sometimes hectic environment and by using your planning and prioritising skills, you meet deadlines and proactively follow up on stakeholders. You will work closely together with teammates, interacting with different internal and external stakeholders. Therefore, it's vital that you possess good communication skills and are committed to getting things done both individually and together with the RA team.
Your key responsibilities:
- Lead and support Regulatory projects.
- Medical device submissions to US and UK/EU.
- Drive renewals and product applications with local Authority.
- Support MDR filling in EU.
- Conduct Regulatory impact assessments.
Qualifications:
- Master’s degree in pharmaceutical, chemistry or biology or similar.
- + 4 years of experience from Regulatory affairs - preferable from medical device.
- Structured and systematic approach.
- Prior experience with FDA 510(k) and EU MDR 2017/745.
- Project management flair and problem-solving skills.
- Proficient level in MS Office.
- Eye for detail.
- Fluent English (spoken and written) is mandatory.
- A can-do attitude, positive mindset and empathic.
- Team player.
Senior Regulatory Affairs Specialist in Falmouth employer: CooperCompanies
CooperSurgical is an exceptional employer that prioritises the well-being of its employees while making a significant impact in the field of fertility and women's healthcare. With a strong commitment to innovation and collaboration, our remote work culture allows for flexibility and work-life balance, while providing ample opportunities for professional growth within a supportive global team. Join us in our mission to enhance the lives of women and families, and be part of a company that values dedication, teamwork, and doing the right thing.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Falmouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with FDA 510(k) and EU MDR. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory processes and recent changes in legislation. We recommend creating a list of common interview questions and practising your responses to show off your expertise and confidence.
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples of how you've successfully led regulatory projects in the past. This will demonstrate your ability to thrive in a dynamic environment, just like CooperSurgical values.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at CooperSurgical, where we’re all about making a difference in women’s healthcare.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Falmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience with FDA 510(k) and EU MDR, and don’t forget to showcase your project management skills. We want to see how you can bring your unique flair to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background aligns with our mission at CooperSurgical. Let us know how you can contribute to enabling patients to experience life's beautiful moments.
Showcase Your Communication Skills:Since you'll be interacting with various stakeholders, it's crucial to demonstrate your communication skills in your application. Use clear and concise language, and make sure to highlight any relevant experiences where you've successfully collaborated with teams or external partners.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application directly 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 CooperCompanies
✨Know Your Regulations
Make sure you brush up on the FDA 510(k) and EU MDR regulations before your interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge practically.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed regulatory submissions or projects. Highlighting your structured approach and problem-solving skills will resonate well with the interviewers.
✨Communicate Effectively
Since the role involves interacting with various stakeholders, practice articulating your thoughts clearly. Use examples that demonstrate your communication skills and how you’ve collaborated with teams in the past.
✨Emphasise Your Team Spirit
CooperSurgical values teamwork, so be ready to discuss how you thrive in a collaborative environment. Share instances where you’ve worked closely with others to achieve a common goal, showcasing your positive mindset and can-do attitude.
