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Regulatory Affairs Specialist
Il y a 2 mois
Senior Regulatory Affairs Specialist
Job DescriptionAbout the Role
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs department, you will be responsible for ensuring that our medical devices comply with all relevant safety and environmental policies and regulations.
Key Responsibilities
- Develop and implement comprehensive regulatory strategies for complex software devices and significant post-market changes.
- Prepare and submit regulatory submissions, including US 510(k), EU MDR Technical File, and global/international submissions.
- Manage regulatory submission deliverables and serve as the point of contact for regulatory activities with internal and external stakeholders.
- Participate in QMS improvement initiatives and drive continuous improvement.
- Review and interpret regulatory guidelines and stay up-to-date with US, EU, and global market regulations.
- Collaborate with the Commercial team to ensure product compliance with applicable regulations and internal procedures.
- Provide regular trainings to the team and manage product change control processes.
About You
We are looking for a customer-first attitude and the following skills and qualifications:
- 5+ years of experience in the medical device industry, with a strong background in Design Controls.
- Proficient knowledge of medical device regulations, including 21CFR, FDA law, MDD, and other global laws and standards.
- Experience in supporting international registrations and/or clinical investigations.
- Proficient computer skills in Microsoft Office and LEAN concepts, methodologies, and deployment.
- Fluent in both written and spoken English.
About Philips
We are a health technology company committed to improving people's lives through innovative solutions. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips.
