Philips · 1 week ago
Regulatory Affairs Specialist (Entry Level)
Cambridge, MA
Full-time
Hybrid
Entry Level
$61K/yr - $100K/yr
2+ years expPhilips is a health technology company dedicated to improving access to quality healthcare. They are seeking a Regulatory Affairs Specialist to assist in developing and implementing regulatory strategies to ensure compliance and safety for medical devices.
B2BConsumer ElectronicsElectronicsLightingWellness
No H1B
Responsibilities
Assist in the implementation of comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects
Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards
Help maintain processes for regulatory filings/ licenses and developing technical contribution by collaborating with central and regional Regulatory Affairs teams
Participate in evaluating product development quality reports and support submissions, coordinate and prepare regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but typically not complex
Perform Change Management activities including hosting meetings to acquire change details for sustaining products in the market, notify geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance, reducing overall regulatory burden while ensuring full compliance
Qualification
Required
Bachelor's degree or equivalent qualification preferably in Regulatory Affairs and/or a science related field
2+ years of experience in Regulatory Affairs in Medical Device
The ability to work cross functionally in a multinational organization
Strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and a high attention to detail
Excellent personal and intercultural skills that include being solution and detailed-oriented, well organized, self-motivated, team player, and a willingness and openness for self-improvement
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote 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
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M
Leadership Team
Neil Mesher
CEO and SVP, UK and Ireland
Recent News
2026-01-22
2026-01-22
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