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Principal Regulatory Affairs Specialist-Coronary Vascular
3 months ago
The Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards.
Your role:
- Advise internal stakeholders (R&D, Marketing, Manufacturing, etc.) regarding laws, regulations, and guidance as they relate to the CV products portfolio to ensure outputs are in alignment with regulatory authority expectations and company objectives.
- Develop and implement global regulatory strategies, including submission risk mitigation, through deep understanding of the product's technical characteristics and regulatory landscape.
- Achieve successful device clearances/approvals for the US, Canada, EU and support licenses/registrations of devices worldwide through creative problem solving and high-quality submissions.
- Mentor and develop other Regulatory Affairs personnel within IGTD Regulatory.
- Present to and communicate with internal stakeholders and regulatory agencies, as needed.
- Provide support as it relates to medical device submissions and certifications during product surveillance and QMS audits, as needed.
- Support regulatory process improvement initiatives, QMS Compliance and other Regulatory activities..
- Reporting to the Director of Regulatory Affairs- Coronary Vascular you will collaborate with worldwide colleagues regarding license renewals/updates and advise sustaining and NPD/product design teams on regulatory strategy and requirements for new products/solutions.
- This Hybrid- San Diego, CA or Plymouth, MN based role may require travel up to 10%.
You're the right fit if:
- You've acquired a minimum of 7 years Regulatory Affairs experience within FDA regulated medical device/technology environments, including-regulatory approvals, submittals (e.g., FDA 510(k), PMA, IDE, EU MDD/MDR, Technical Documents) in an area relevant to cardiovascular, imaging, sterile disposable, and/or hardware/software devices.
- You have experience with SaMD and Artificial Intelligence/Machine Learning (desired).
- You have demonstrated Regulatory Domain knowledge and expertise (domestic/international) by leading others in global regulatory matters of diverse product categories.
- You have a minimum of a bachelor's degree (Required), preferably in Regulatory Affairs/Science and/or a science or engineering-related field. masters degree-desired. RAPS RAC credential is a plus.
- You have strong written, oral, and interpersonal skills to effectively compose agency submissions, interface cross-functionally, and complete assignments with minimal supervision.
- You're proficient in Microsoft Office, able to manage multiple tasks, and perform your work creatively and with attention to detail.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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 improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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.
Philips Transparency Details:
The pay range for this position is $97,000 to $178,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
