Director Regulatory Affairs
Cochlear Bone Anchored Solutions AB / Chefsjobb / Göteborg
2025-01-13
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hela Sverige 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.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-07-12
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-620876".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cochlear Bone Anchored Solutions AB (org.nr 556561-7114)
Arbetsplats Cochlear
Kontakt Martin Karlsson
makarlsson@cochlear.com Jobbnummer 9098499