CooperSurgical Fertility Solutions is the global leader in IVF and reproductive genetics, providing innovative products, services and training for every step in the ART journey.
Healthy women, babies, and families™
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 hybrid from our new office in Ballerup, Denmark. The Sr. RA specialist will be reporting to the senior manager also working out of Copenhagen.
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 focus on US and Canada. You will identify and maintain documentation including updates and review of the technical files for the IVF media product portfolio and support the MDR filling (class III). You will maintain the regulatory QP/QI´s in the quality management system in corporation 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 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'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.
- New product registrations in Canada & US
- Drive renewals and product applications with local Authority
- Support MDR filling in EU.
- Conduct Regulatory impact assessments.
Your Qualifications
- Master’s degree in pharmaceutical, chemistry or biology or alike
- + 4 years of experience from Regulatory affairs -preferable from medical device
- Structured and systematic approach
- Prior experience with K510 and EUMDR
- 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
Why join CooperSurgical?
We can offer a challenging position within a dynamic, globally leading, high growth company. You will work together with competent colleagues in a positive environment, that welcomes people of all views and backgrounds and provides countless ways to grow and develop.
Interested?
Apply here.
To ensure we continue improving the quality of treatments for women and families, we offer roles that challenge individuals, helping them grow. To make this happen we provide high-quality training, and through collaborative project work and peer support, we believe our work environment helps to nurture talent enabling everyone to excel.
