Principal Regulatory Affairs Specialist-Coronary Vascular
2 months ago
Lead Regulatory Affairs Specialist-Coronary Vascular
Job Summary
As a Lead Regulatory Affairs Specialist, you will have a key role in ensuring the safety, effectiveness, and compliance of Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products with global regulatory standards.
Role Highlights:
- Provide guidance to internal teams (R&D, Marketing, Manufacturing, etc.) on laws, regulations, and guidelines related to the CV product line to ensure alignment with regulatory expectations and company goals.
- Develop and execute global regulatory strategies, manage submission risks, and secure approvals for the US, Canada, EU, and other regions through innovative problem-solving approaches.
- Mentor and lead Regulatory Affairs staff, engage with stakeholders and regulatory agencies, and support product certifications and audits.
- Collaborate with the Director of Regulatory Affairs-Coronary Vascular and global teams on license renewals, NPD strategies, and regulatory requirements.
- This role is Hybrid in San Diego, CA or Plymouth, MN with occasional travel.
- No relocation assistance is offered; candidates must be situated near Plymouth, MN or San Diego, CA.
- 7+ years of Regulatory Affairs experience in FDA-regulated medical device environments, including approvals, submissions, and knowledge in cardiovascular, imaging, and hardware/software devices.
- Experience with SaMD and Artificial Intelligence/Machine Learning is a plus.
- Strong expertise in domestic and international regulatory requirements, a Bachelor's degree is required, Master's preferred. RAPS RAC credential is advantageous.
- Excellent communication skills, proficiency in Microsoft Office, and ability to handle tasks independently.
- US work authorization is essential; sponsorship is not available.
Philips is a leading health technology company dedicated to providing quality healthcare globally. We prioritize inclusivity and aim to make healthcare accessible to all. Join us in making a difference.
- Explore our business initiatives.
- Learn about our rich history.
- Understand our mission and values.
- Discover our employee perks.
Philips Compensation:
The salary range for this role is $97,000 to $178,000 per year, dependent on experience, skills, and location.
This job posting will be active for 45 days or until filled. Early applications are recommended. Philips is an equal opportunity employer, promoting diversity and creating an inclusive workplace environment.
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