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Regulatory Affairs Principal Specialist

The Principal Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role will provide day to day regulatory support for new product development and sustaining activities including, but not limited to, change order support, regulatory planning, and other activities as directed by management.

Your role:

• The Principal Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.

• Author 510(k) submission, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process.

• Participate in strategic product development, design solutions starting from concept phase to the product delivery phase and provide regulatory guidance throughout design and development.

• Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines.

• Support activities required to maintain regulatory compliance as new or revised versions of standards; guidance documents are published.

• Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert.

• Review labelling, 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.

• Mentoring and coaching other regulatory team members and provide regulatory guidance.

You're the right fit if:

• Minimum of 12 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience, 510(k) submission experience is preferred.

• Preferred candidate will have a master’s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors’ Degree with demonstrated experience working within Medical Device industry. Prior experience working with Sleep and Ventilator products is bonus.

• Expert in understanding, interpretations, and the application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.

• Prior experience supporting/leading regulatory submissions such as 510k, EU MDR Technical Documentations and global registrations.

• You have strong written, oral, and interpersonal skills to be able to work in a team environment as well as individual contributor with minimal supervision.

• Solution and detail oriented, well organized and self-motivated, and good communication skills with ability to negotiate with regulators.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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• Discover our rich and exciting history.

• Learn more about our purpose.

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. Learn more about our commitment to diversity and inclusion here.

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