Principal Regulatory Affairs Specialist

Job Title

Principal Regulatory Affairs Specialist

Job Description The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products in the U.S., EU, and Rest of World products.

Your Role

• Author 510K submissions, pre-sub documents, EUMDR tech files, and will contribute to international regulatory submissions.
• Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development.
• Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Able to manage special projects across a spectrum of product lines.
• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.
• Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
• Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory SME.
• Review labeling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
• Identify areas for improvement for efficiency improvement and compliance in internal processes, work instructions, and forms. Apply technical expertise to process improvement efforts.

You're The Right Fit If

• You’ve acquired a minimum of 7+ years’ experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments.
• You have proven expertise in Software as a Medical Device (SaMD), IEC 82304 (safety) and IEC 81001-5-1/ISO 27001 (Information Security).
• You have authored multiple 510Ks, with proven experience in EUMDR tech files, and Pre-Sub notifications submitted to the FDA.
• Your skills include familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations.
• You have knowledge and understanding of the software development lifecycle (SDLC).
• You have a minimum of a Bachelors’ Degree (Required). RAPS certification- preferred.
• You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How We Work Together We believe that we are better together than a part. 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 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 our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

• The pay range for this position in Murrysville, PA and New Kensington, PA is $114,750 to $183,600.
• The pay range for this position in Cambridge, MA is $128,520 to $205,632.

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. 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.

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.

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 will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA or New Kensington, PA or Cambridge, MA.
• May travel up to 10%

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.