Senior RA Specialist

What will you do:

• Supports assessment of regulatory requirements stakeholder expectations and emerging regulatory trends and highlights potential impacts to regulatory to execution of regulatory strategies by supporting global regional and multi-country submission activities

• Assists in identifying regulatory pathways for product changes and supports documentation required for submissions. Supports evaluation of regulatory requirements for product lifecycle activities including design labeling and manufacturing changes

• Coordinates preparation compilation and submission of regulatory dossiers (e.g. FDA 510(k) EU MDR Technical Files emerging market submissions).Ensures completeness accuracy and compliance of submission documentation in alignment with regulatory requirements

• Maintains and updates regulatory information management systems (RIM) to track submissions approvals and renewals. Supports change control processes by coordinating regulatory impact assessments and associated documentation

• Collaborates with cross-functional teams (R&D Quality Clinical Marketing) to gather required inputs for regulatory submission timelines dependencies and deliverables to ensure on-time execution

• Supports responses to regulatory authority queries by compiling and organizing required documentation. Maintains regulatory documentation technical files and dossiers in an audit-ready state

• Supports publishing activities for electronic and paper submissions (eCTD/non-eCTD formats). Assists in monitoring regulatory changes and supports impact assessments under guidance of senior regulatory staff

• Contributes to development maintenance and improvement of regulatory processes SOPs and templates. Supports internal audits and inspections by ensuring availability and accuracy of regulatory documentation

• Provides operational support for ensuring product compliance with applicable regulations (FDA EU MDR ISO standards etc.)Coordinates with global regulatory teams to ensure alignment and consistency in submission documentation and processes

What You Need:

• Bachelors degree in Engineering Life Sciences Pharmacy or related field; advanced degree 36 years of experience in Regulatory Affairs Regulatory Operations or related function within medical devices/pharma

• Experience with regulatory submissions documentation or publishing preferred

• Exposure to global regulatory frameworks (FDA EU MDR TGA NMPA PMDA CDSCO etc.) is desirable

Knowledge / Competencies:

• Demonstrates strong understanding of regulatory processes submission requirements and documentation knowledge of applicable regulations standards and guidance documents to support compliant execution of regulatory activities

• High attention to detail with ability to manage and review large volumes of documentation organizational and project coordination skills with the ability to manage multiple deliverables and timelines

• Effectively collaborates with cross-functional stakeholders to gather inputs and drive timely completion of tasks. Communicates clearly and professionally in both written and verbal formats

• Demonstrates a process-oriented mindset with focus on consistency standardization and efficiency. Identifies opportunities for process improvements and supports implementation of best practices

• Works independently on assigned tasks while seeking guidance for complex issues. Demonstrates adaptability in a fast-paced global and matrixed environment

• Maintains high level of accountability and ownership for deliverables. Embraces feedback and continuously works toward improving performance and capabilities