Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.
Are you a seasoned professional in Regulatory Affairs looking to make a significant impact on a global scale? Cochlear Limited, a leader in implant, sound processor, and acoustics products, is seeking a dynamic Director of Regulatory Affairs. In this pivotal role, you will lead our CBAS Regulatory team based in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide. Your leadership will drive cross-functional partnerships and alignments, contributing to our mission of transforming lives.
Key Responsibilities:
Strategic Leadership:
Shape and execute global regulatory strategies.
Mentor and guide your team to provide critical regulatory insights for Cochlear’s Product Innovation Process (PIP).
Present strategic recommendations to CBAS leaders and Regional Regulatory teams.
Oversee multiple high-priority projects, ensuring successful outcomes.
Forge strong relationships and negotiate with external regulatory bodies.
Communicate effectively with all stakeholders to foster teamwork and alignment.
Deliver impactful business and technical briefings to key stakeholders.
Operational Excellence:
Develop and optimize systems for tracking regulatory submissions and commitments.
Lead the team in managing change controls and submission requirements.
Regulatory Compliance:
Serve as the appointed “Person Responsible for Regulatory Compliance” (PRRC).
Review and approve labelling materials.
Address European regulatory requirements for recalls and adverse event filings.
Participate in regulatory audits and inspections.
Maintain QMS procedures related to Regulatory Affairs.
Team Development:
Attract, develop, and retain top talent to achieve Cochlear’s business objectives.
Provide regular feedback and coaching to foster growth and success.
Champion workplace health and safety initiatives.
Key Requirements:
Minimum:
Bachelor’s degree in a related field with extensive experience in Regulatory Affairs.
Knowledge of at least two medical device jurisdictions (e.g., FDA, TGA, EU MDR).
Proven experience in healthcare, regulatory affairs, and medical devices.
Expertise in financial mechanisms and budget management.
Demonstrated ability to lead teams and collaborate with People and Culture.
Exceptional attention to detail and proficiency in English.
Ability to thrive in a fast-paced, dynamic environment.
Ideal:
Master’s degree in a related field.
Strong negotiation and influencing skills for optimal commercial outcomes.
RAPs certification.
A Little About Cochlear
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha).
#cochlearcareers #TogetherCochlear
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