Regulatory Affairs Lead
4 weeks ago
About the Role
At Philips, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and RoW.
Key Responsibilities
- Develop and execute regulatory strategies for new product development, design changes, and field safety corrections.
- Author 510(k) submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead interactions with regulators/competent authorities throughout the review and approval process.
- Participate in strategic product development, design solutions starting from the concept phase to product delivery phase, and provide regulatory guidance throughout the design and development process.
- Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to other RA staff and project teams.
- Monitor global regulatory landscapes and guide cross-functional teams on the implementation of regulation changes.
- Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with regulatory requirements.
- Support product defect assessments, issue impact assessments, health hazard evaluations, corrections, and removals, and CAPAs as a regulatory subject matter expert.
- Review labeling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
- Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts.
- Lead or participate on process improvement teams to affect changes at a local or cross-business unit level.
- Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance.
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