Philips
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Senior Regulatory Affairs Specialist
role at
Philips .
For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Overview The Senior Regulatory Affairs Specialist (Ultrasound) recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and guide junior team members. The role also manages change activities for sustaining products, ensuring regulatory partners are informed of key updates. Responsibilities
Serve as RA Representative on project teams, develop regulatory submission strategies for new product launches, and provide regulatory guidance to project teams. Coordinate planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentation to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents. Qualifications
5+ years of experience in medical device regulatory affairs and/or quality assurance. Experience authoring SaMD or SiMD submissions strongly preferred. Experience authoring US 510k and EU MDR Tech Files required. Knowledge of quality system requirements and FDA and/or international product approval process; track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510Ks. Bachelor’s degree or higher in a related field. RAPS RAC preferred. Ability to meet minimum physical, cognitive and environmental job requirements for an office/remote position with or without accommodation. 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 generally done outside the main facilities at customers’ or suppliers’ locations. This is an office-based role. 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 quality healthcare. Do the work of your life to help improve the lives of others. Philips Transparency Details The pay ranges vary by location: Reedsville, PA: $87,000–$139,200; Plymouth, MN: $91,350–$146,160; Bothell, WA and Cambridge, MA: $97,440–$155,904. The actual base pay offered may vary based on factors including knowledge, experience, business needs, location, and equity. Other compensation such as annual incentive bonus, sales commissions or long-term incentives may be offered. Philips Total Rewards includes benefits such as PTO, 401k, HSA, stock purchase plan, education reimbursement, etc. Details about benefits are available here. Additional Information US work authorization is a precondition of employment. Company relocation benefits are not provided. You must reside in or within commuting distance to posted locations. This requisition is expected to stay active for 45 days but may close earlier if a candidate is selected or business needs dictate. Apply soon to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Job metadata
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal Industry: Hospitals and Health Care
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Senior Regulatory Affairs Specialist
role at
Philips .
For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Overview The Senior Regulatory Affairs Specialist (Ultrasound) recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and guide junior team members. The role also manages change activities for sustaining products, ensuring regulatory partners are informed of key updates. Responsibilities
Serve as RA Representative on project teams, develop regulatory submission strategies for new product launches, and provide regulatory guidance to project teams. Coordinate planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentation to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents. Qualifications
5+ years of experience in medical device regulatory affairs and/or quality assurance. Experience authoring SaMD or SiMD submissions strongly preferred. Experience authoring US 510k and EU MDR Tech Files required. Knowledge of quality system requirements and FDA and/or international product approval process; track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510Ks. Bachelor’s degree or higher in a related field. RAPS RAC preferred. Ability to meet minimum physical, cognitive and environmental job requirements for an office/remote position with or without accommodation. 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 generally done outside the main facilities at customers’ or suppliers’ locations. This is an office-based role. 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 quality healthcare. Do the work of your life to help improve the lives of others. Philips Transparency Details The pay ranges vary by location: Reedsville, PA: $87,000–$139,200; Plymouth, MN: $91,350–$146,160; Bothell, WA and Cambridge, MA: $97,440–$155,904. The actual base pay offered may vary based on factors including knowledge, experience, business needs, location, and equity. Other compensation such as annual incentive bonus, sales commissions or long-term incentives may be offered. Philips Total Rewards includes benefits such as PTO, 401k, HSA, stock purchase plan, education reimbursement, etc. Details about benefits are available here. Additional Information US work authorization is a precondition of employment. Company relocation benefits are not provided. You must reside in or within commuting distance to posted locations. This requisition is expected to stay active for 45 days but may close earlier if a candidate is selected or business needs dictate. Apply soon to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Job metadata
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal Industry: Hospitals and Health Care
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