Regulatory Affairs Senior Specialist

#Li-Onsite

At CooperSurgical, we are currently looking to recruit a Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This role focuses primarily on the US (FDA), Canada (Health Canada) and Australia (TGA) markets, ensuring compliance and supporting submissions that enable patients and healthcare professionals to access our innovative fertility and women’s health solutions worldwide. 

You will report to the Regulatory Affairs Manager based in Denmark/Spain and collaborate closely with colleagues across RA, QA, R&D, Supply Chain, and commercial teams. 

Location: Copenhagen Denmark or Barcelona Spain

Workplace: Onsite

The Role

As Regulatory Affairs Specialist, you will take ownership of regulatory activities in the US, Canadian, and Australian markets. This includes regulatory submissions, renewals, license notifications, and product change assessments (letters-to-file / not-to-file). You will also contribute to 510(k) submissions, ensuring documentation is accurate, compliant, and delivered on time. 

This is a dynamic position where you will balance regulatory rigor with proactive planning. You will thrive if you enjoy driving projects forward, working with cross-functional stakeholders, and keeping a structured overview in a busy, fast-moving environment.  

The position as RA Specialist is vital for the success and growth of CooperSurgical. 

Key Responsibilities

• Lead regulatory activities for US, Canada and Australia. Preparing, submitting, and maintaining files and legalized documentation. 
• Perform regulatory assessments of product changes, including letter-to-file / not-to-file decisions. 
• Manage annual renewals, license maintenance, and regulatory notifications. 
• Support the preparation of 510(k) submissions and updates to technical documentation. 
• Coordinate collection and review of data for international registrations. 
• Partner with global RA colleagues and cross-functional teams to ensure timely and compliant submissions. 
• Carry out administrative and procedural tasks within the RA function. 

Qualifications

• MSc in Engineering, Bioscience, Technical or related field. 
• 3–5 years of experience in Regulatory Affairs, ideally within the medical device / life science sector. 
• Proven experience with global submissions, preferably including FDA, Health Canada, and/or TGA. 
• Familiarity with 510(k) processes and change control assessments. 
• Strong organizational and prioritization skills; structured and systematic work approach. 
• Excellent communication and problem-solving skills. 
• Fluent in English (written and spoken). 
• Proficiency with MS Office applications. 
• A proactive, “can-do” mindset and ability to work both independently and in global teams. 

Why Join Coopersurgical?

At CooperSurgical, you will be part of a dynamic, high-growth, global leader in fertility and women’s health. We offer: 

• A role with real impact in helping families around the world. 
• The chance to work alongside talented, supportive colleagues in an inclusive and international environment. 
• Opportunities for professional growth, learning, and career development. 
• A positive workplace culture that values different perspectives and encourages innovation.