Job Overview: We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our team. This role is crucial in providing regulatory support throughout the lifecycle of Cochlear products. The Senior Regulatory Affairs Specialist will work closely with R&D cross-functional project teams, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements.
Key Responsibilities:
Regulatory Strategy and Planning: Support project teams with regulatory and standards compliance advice through product development. Define documentation needs and ensure they are delivered to quality and timeline requirements. Develop regulatory strategies in collaboration with regional regulatory teams, to support business plans for products or projects. Participate in strategic regulatory and continuous improvement projects as required.
Regulatory Submissions and Related Activities: Prepare and manage the submission process to gain new or modified product approvals and maintain product licenses. Adapt or create technical dossiers for regional market submissions and coordinate support for regional subsidiaries, offices, and distributors. Ensure timely regulatory assessments of sustaining changes, including submissions or the necessary documentation of them (e.g. Letter to File).
Cross-Functional Regulatory Direction: Evaluate labeling and manufacturing changes and promotional material for regulatory impact. Provide regulatory direction to the business and inform the organization about new or changing national regulations/trends and propose implementation plans. Drive the implementation of better regulatory practices and processes.
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.
Excellent review, report writing and documentation skills.
Knowledge of global regulatory requirements and regulations for medical devices, with an emphasis on MDR.
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.
Work Experience:
3+ years’ experience in regulatory affairs, including a track record of management, compilation, submission, and maintenance of regulatory filings.
3+ years’ experience in medical devices product or software development (SaMD).
Ideally worked in a global matrix organization including manufacturing and logistics.
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