Regulatory Affairs Specialist

Cochlear is hiring a Regulatory Affairs Specialist. Level rates it ; you can apply on Cochlear.

Level's read on this job

On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
Level classifies it as a mid-level role.
Level lists 102 other open roles at Cochlear.
The role was posted in the last few days.

AI in this role

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. 🎧

#RegulatoryAffairs #MedicalDevices #Healthcare #EMEAJobs #Regulatory #CochlearCareers

How we rate this

Regulatory Affairs Specialist at Cochlear rates 37 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.