Senior Regulatory Specialist

15 hours ago


Gothenburg, Västra Götaland, Sweden Cochlear Bone Anchored Solutions AB Full time
Job Description
We are seeking a skilled Senior Regulatory Affairs Specialist to join our team. This role requires providing regulatory support throughout the lifecycle of our products and ensuring compliance with regulatory requirements. The ideal candidate will have experience in regulatory affairs, including management, compilation, submission, and maintenance of regulatory filings.

Main Responsibilities:
* Collaborate with regional regulatory teams to develop regulatory strategies that support business plans for products or projects.
* Prepare and manage submissions to gain new or modified product approvals and maintain product licenses.
* Evaluate labeling and manufacturing changes and promotional material for regulatory impact and provide regulatory direction to the business.

Requirements:
* Proven track record of managing regulatory filings and maintaining compliance with regulatory requirements.
* Strong communication and influencing skills to work effectively with cross-functional teams and stakeholders.
* Ability to balance business interests and regulatory risk to provide sound advice and recommendations.

Preferred Qualifications:
* Regulatory Affairs Certification (RAC).

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