General:
- Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards.
- Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements.
- Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes.
- Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables.
Regulatory Documentation
- Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance.
- Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product labeling to meet global regulatory and market requirements.
- Serve as a subject matter expert, providing advanced regulatory guidance and interpretation of compliance standards and associated testing strategies.
- Advise and collaborate with cross-functional teams on regulatory considerations in design and development projects, influencing product and process decisions.
- Manage and approve change notifications submitted to Notified Bodies and Regulatory Authorities, ensuring timely and accurate communication.
- Drive and oversee conformity assessments for new medical devices (nMD), medical devices (MD), and other regulated products, ensuring alignment with risk classifications and applicable standards.
- Author and validate expert opinions and risk evaluations to support product compliance documentation.
- Conduct the preparation of the technical content for Clinical Evaluation Plans and Reports, ensuring robustness and regulatory adequacy.
Product Registration
- Ensure and strategically guide regulatory product availability in global markets in support of the company’s business objectives and commercial strategy.
- Maintain oversight of global regulatory requirements and activities, providing expert coordination and direction to regional teams and stakeholders.
- Define, align, and communicate regulatory strategies and roadmaps in partnership with cross-functional and regional partners.
- Oversee the execution and maintenance of product registrations, renewals, and submissions worldwide, resolving complex regulatory challenges proactively.
- Direct the compilation of standardized global registration files (e.g., STED) and lead their adaptation for local submissions.
- Approve Free Sale Certificates and declarations for regulatory submissions, ensuring accuracy and compliance.
- Lead the registration of medical devices (including trading goods and kits), production sites, and new production lines, ensuring adherence to applicable laws and guidelines.
- Provide senior-level support and strategic input for pharmaceutical registrations where medical devices are classified as medicinal products.
- Represent Regulatory Affairs in tenders, delivering regulatory documentation and strategic input as needed.
Change Management
- Chair or lead participation in design change councils, providing authoritative regulatory direction on change control processes.
- Evaluate, approve, and guide the implementation of complex product and process changes from a global regulatory perspective.
- Lead global communication and alignment of regulatory changes across regions and stakeholders, ensuring consistency and compliance.
- Oversee and validate local assessments of regulatory impacts and drive resolution of feedback and challenges.
- Monitor and report on the implementation of changes, maintaining high-level oversight of status, risks, and mitigation plans.
- Act as regulatory project leader for significant change initiatives, ensuring timely delivery and compliance.
Support, Creation, and Review
- Lead the drafting, review, and approval of Declarations of Conformity and related compliance documentation.
- Oversee the creation, maintenance, and governance of Product Center Information and other regulatory data repositories.
- Provide senior-level review and decision-making on Additional Information (AI), Supplementary Requests (SR), and other regulatory inquiries.
- Guide and approve product-related technical documentation, marketing materials, and other customer-facing content from a regulatory standpoint.
- Maintain, review, and enhance the global list of applicable standards, ensuring currency and alignment with evolving regulatory landscapes
