Principal Regulatory Affairs Specialist
1 month ago
Job Title
Principal Regulatory Affairs Specialist
Job Description
Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based)
The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organization globally. You will work closely with various stakeholders from global Philips Innovation Hubs, and regulatory leaders from different clusters, to enable and accelerate regulatory approvals for innovative solutions in all target markets.
Your role:
You're the right fit if:
You’ve acquired 7+ years of experience in the FDA regulated Medical Device industry executing regulatory strategies, compiling technical documentations and regulatory submission packages for software enabled medical devices. Your skills include experience or working knowledge of applicable standards including software development lifecycle, risk management and cybersecurity in medical devices required. Experience in executing regulatory strategies for AI enabled Medical Devices preferred. Experience with US FDA pre-submissions, 510(k) submissions required. Experience with US FDA De Novo, CE marking under MDD/MDR and international registration in emerging markets such as India-preferred. Ultrasound and Obstetrics device experience is a plus. You have a bachelor’s of science degree or higher in a technical discipline; Master’s preferred. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You’re an excellent communicator, with strong project management and stakeholder management skills,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 . Discover Learn more about Read more about .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 .
Philips Transparency Details
The pay range for this position is $104,300 to $200,256, 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.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found .
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
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.
Company relocation benefits be provided for this position. For this position, you must reside in within commuting distance to posted location(s) .
#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.
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