Regulatory Affairs Senior Specialist

Job Description

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .

Responsibilities

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.

Responsibility

• 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.
  
  
  

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