Regulatory Affairs Specialist

Help Bring Life-Changing Medical Devices to Patients

At Cochlear, our mission is to help people hear and be heard. Regulatory Affairs plays an essential role in making sure our innovative medical device solutions meet regulatory requirements and can reach the people who need them.

We're looking for an EU Regulatory Affairs Specialist to help bring innovative medical device solutions to patients across EMEA.

About the Role

Working closely with Regulatory Affairs, Product Development, Clinical Affairs, Quality, and other cross-functional teams, you'll provide regulatory guidance throughout the product lifecycle.

You'll support regulatory strategy, manage submissions to EU Notified Bodies and regulatory authorities, and assess product, labelling, and manufacturing changes.

What You'll Do

• Develop and support regulatory strategies for products across EMEA
• Provide regulatory and standards compliance guidance throughout product development
• Prepare and manage regulatory submissions for new and modified products in the EU and UK
• Create and maintain technical documentation, product registrations, licences, renewals, and post-approval commitments
• Assess product, labelling, manufacturing, and promotional changes for regulatory impact
• Work with Manufacturer Regulatory Affairs, Notified Bodies, regulatory authorities, and cross-functional teams
• Monitor regulatory changes and support CAPA activities, audits, inspections, and continuous improvement initiatives

What You'll Bring

• Bachelor's degree in a scientific, healthcare, legal, or related discipline
• 3+ years of experience in Regulatory Affairs, medical devices, product/software development, and/or quality
• Knowledge of regulatory requirements for medical devices
• Experience with regulatory submissions and technical documentation
• Strong communication, documentation, and stakeholder management skills
• Ability to balance business needs with regulatory requirements and make sound decisions
• Fluent English, both written and spoken

Preferred

• Master's or doctoral degree in a relevant discipline
• Regulatory Affairs Certification (RAC)
• Experience in medical device product or software development
• Experience working with EU Notified Bodies and regulatory authorities

Why Cochlear?

✅ Make a real difference in the lives of people with hearing loss

✅ Comprehensive onboarding and product training program

✅ Competitive salary, bonus scheme, and annual salary reviews

✅ 30 days' annual leave plus additional days off on Christmas Eve and New Year's Eve

✅ Flexible working hours and hybrid working

✅ Employee share plan, Corporate Benefits, childcare support, and sabbatical options

✅ Ongoing learning and development opportunities

✅ Modern office environment, free parking, and excellent transport links

✅ Collaborative culture with regular feedback, team events, sports activities, and social initiatives

If you're passionate about Regulatory Affairs, medical devices, and bringing innovative healthcare solutions to patients, we'd love to hear from you.

Apply now and help us connect people to a world of sound. 🎧

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