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Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the approval of our medical devices.
Key Responsibilities- Regulatory Strategy and Planning
Develop and implement regulatory strategies to ensure compliance with FDA and international regulations.
Submission Preparation and CoordinationPrepare and coordinate regulatory submissions to FDA, EU, and other worldwide government agencies.
Regulatory Interactions and NegotiationsNegotiate and interact with regulatory authorities to ensure timely submission approval.
Regulatory Document ManagementMaintain accurate and verifiable regulatory documentation to support compliance and traceability.
Quality System Audits and ComplianceParticipate in internal and external quality system audits and ensure compliance with regulatory requirements.
Requirements- Experience
5+ years of experience in medical device regulatory or quality assurance field.
EducationBachelor's degree in life sciences or a related field.
SkillsKnowledge of quality system requirements and FDA and/or international product approval process.
Physical, Cognitive, and Environmental Job RequirementsAbility to successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation.
About PhilipsWe are a health technology company dedicated to improving the lives of patients and healthcare professionals around the world. Our purpose is to make a meaningful difference in the lives of others, and we are committed to creating a better and fairer future for all.
Compensation and BenefitsThe pay range for this position is $77,000 to $136,000 annually. In addition to a competitive salary, we offer a comprehensive benefits package, including a generous PTO, 401(k) plan, HSA, stock purchase plan, education reimbursement, and more.
