Principal Regulatory Engineer
The Principal Regulatory Engineer for the CT/AMI business leads global regulatory planning and strategy for product registrations, oversees worldwide submissions and post-market surveillance, and ensures quality and compliance with relevant regulations. They provide regulatory guidance on risk management, labeling, design, and audits, supporting both sustaining and new product development throughout the product life cycle.
Your role:
Lead regulatory planning and strategy for global product registrations (including 510(k), CE Marking under MDD/EU MDR, Technical Files), and oversee worldwide product submissions and post-market surveillance.Advise on regulatory risk assessment, corrective actions, and compliance with global standards (such as ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001), and participate in program meetings to ensure alignment with international requirements.Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance.Drive improvements in Quality System processes, document procedures for effective system maintenance, and play a key role in internal and external audits (including FDA, SFDA, KFDA, JPAL, and notified bodies).Serve as Regulatory Affairs representative for CT/AMI Systems, guiding risk management, defect and complaint review, and supporting regulatory aspects throughout the Development Life Cycle.You're the right fit if:
You’ve acquired 7+ years of experience with SaMD/SiMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in Medical Devices Industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product development is ideal.Your skills include knowledge and experience with regulatory compliance and engineering standards related to safety like radiation and emitting product standards, as well as other standards related to SaMD (60601, 21 CFR parts 1000 and 1001 for radiation emitting devices, and XR 25, 26, 28, and 29, ISO 13485 & 14971, etc.).You have a bachelor’s degree or higher in an engineering or scientific area preferred. RAPS RAC certified 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 (written and verbal) with a strong ability to work cross-functionally. You must be willing and able to travel up to 15% domestically and globally as needed.How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office-based role.
About Philips
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The pay range for this position in Orange, OH is $114,750 to $183,600.
The actual base pay offered may vary within the posted ranges 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 here.
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.
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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.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.