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 growth and collaboration across international teams.
- Why this job: Make a real impact on women's health and family care globally.
- Qualifications: Master’s degree and 4+ years in regulatory affairs, preferably in medical devices.
The predicted salary is between 45000 - 60000 £ per year.
Senior Regulatory Affairs Specialist
Cooper Surgical 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 Cooper Companies, 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.
Company
Cooper Surgical 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.
Responsibilities
At Cooper Surgical 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 report to the RA manager, who is also based in the UK.
Position
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 filing (class I, IIa).
You will maintain the regulatory QP/QI’s within 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, using your planning and prioritizing 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 is 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 filing in EU.
- Conduct Regulatory impact assessments.
Qualifications
- Master’s degree in pharmaceutical, chemistry or biology or similar.
- +4 years of experience in Regulatory affairs – preferably 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.
- Job Info
- Job Identification: 10909
- Job Category: Compliance, Risk & Legal
- Job Schedule: Full time
- Job Shift: Day
Locations: Falmouth, Cornwall, United Kingdom; Barcelona, Spain; Berlin, Germany; Italy; Ballerup, Hovedstaden, Denmark; Netherlands; France (Remote)
- Company: Cooper Surgical
- #J-18808-Ljbffr
Senior Regulatory Affairs Specialist employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
