Job Title
Principal Regulatory Affairs Specialist-Coronary Vascular
Job Description
The Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and providing regulatory guidance for Sustaining and New Product Development/Design initiatives for our Image Guided Therapy Devices/Coronary Vascular team.
Your role:

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, especially around SW including AI and ML etc. to ensure regulatory strategy is in alignment with company objectives and ensures standard and process compliance.
• Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy.
• Responsible for product registration submissions/approvals for the US, Canada, EU and selected worldwide locations. Review and approve advertising, promotional items and labeling for regulatory compliance.
• Identify potential regulatory approvals risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.
• Lead a team within Regulatory or Cross Functional Team to set and deliver the objectives. Mentor other regulatory affairs personnel within IGTD Regulatory.
• Communicate application progress to internal stakeholders and with regulatory agencies as needed.
• Provide audit, CAPA and post market regulatory support. Maintain regulatory files and tracking databases as required.
• 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 based role may require travel up to 10% (some international).

You're the right fit if:

• You've acquired a minimum of 10 years' Regulatory Affairs experience within FDA regulated medical device/technology environments, including-regulatory approvals, submittals-FDA 510K, PMA, IDE, EU MDD/MDR, Health Canada, Technical Files/Design Dossiers, SaMD and familiarity with Artificial Intelligence/Machine Learning.
• You have demonstrated Regulatory Domain knowledge and expertise (Domestic/International) in leading others in global regulatory matters of diverse product categories (implants, software, combination products, biologics, install base equipment, etc)
• You have a minimum of a Bachelor's Degree, preferably in Regulatory Affairs and/or a science related field (Required). Master's degree desired. RAPs RAC strongly preferred.
• You have strong written, oral, and interpersonal skills to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
• You're proficient in Microsoft Office, able to manage multiple tasks, perform with accuracy/high attention to detail and understand LEAN concepts, methodologies, and deployment.
• 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.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.