Regulatory Affairs Professional
17 hours ago
Cochlear Bone Anchored Solutions AB is seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to provide regulatory support throughout the lifecycle of our products. This role involves working closely with cross-functional project teams, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements.
Key Responsibilities:
* Develop regulatory strategies in collaboration with regional regulatory teams to support business plans for products or projects.
* Prepare and manage the submission process 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.
Qualifications:
* Proven experience in regulatory affairs, including management, compilation, submission, and maintenance of regulatory filings.
* Strong skills in influencing in a matrix team environment and managing stakeholders at all levels within the business.
* Ability to make judgments and provide advice that balances business interests and regulatory risk.
Certifications:
* Regulatory Affairs Certification (RAC) is highly desirable.
Education:
* Minimum Bachelor's degree in engineering, legal, scientific, or healthcare; or 3+ years' experience in software or product development, quality, and/or regulatory affairs.
Languages:
* English - Advanced/Fluent.
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