Principal Regulatory Affairs Specialist

Job Title

Job Description

The Principal Regulatory Affairs Specialist plays a critical leadership role as a Senior regulatory subject-matter expert ensuring Philips medical device products are safe effective and compliant with applicable global regulatory requirements with a primary focus on US/FDA 510(k) EU MDR and complex hardware-based medical systems including international market expansion (e.g. Japan and Canada).

Your role:

• Serve as a Principal Regulatory expert for 510(k) and EU MDR compliance including interpretation and application of regulations guidance and standards across integrated hardware systems and complex device portfolios.
• Lead and influence global regulatory strategies to support market expansion and lifecycle management with emphasis on system-level hardware integration considerations for US EU Japan Canada and other international markets as required.
• Provide regulatory leadership and strategic guidance to internal stakeholders (R&D Quality Clinical Marketing Manufacturing Supply Chain etc.) to ensure regulatory requirements are embedded into hardware system architecture design inputs verification and validation activities.
• Drive preparation review and maintenance of EU MDR Technical Documentation including oversight of conformity assessment activities and interactions with Notified Bodies.
• Partner closely with hardware and systems engineering teams to support regulatory assessments of:
  • System-level risk management and hazard analysis
  • Hardware/software interfaces
  • Design changes and impact assessments
  • Verification and validation strategies for integrated systems
• Support and/or lead international regulatory submissions registrations and renewals including coordination of submission strategies gap assessments and risk mitigation plans.
• Act as a key regulatory interface during Notified Body audits regulatory inspections and QMS audits including preparation participation and follow-up activities.
• Provide regulatory input for post-market surveillance vigilance and change management ensuring ongoing compliance throughout the product lifecycle.
• Mentor and provide technical leadership to other Regulatory Affairs professionals supporting capability development and consistent regulatory execution.
• Communicate complex regulatory topics clearly and effectively to senior leadership and cross-functional teams enabling informed decision-making on hardware design tradeoffs and system integration risks.

Youre the right fit if:

• Youve acquired a minimum of 8 years experience in Regulatory Affairs within FDA regulated Medical Device environments including 510(k)s PMA supplements EU MDR Technical Documents and pre-submissions.
• You have proven expertise/knowledge in Regulations/Standards for hardware (IEC 60601) Software (IEC 62304) Risk Management (ISO 14971) and experience with SaMD (IEC 82304) is preferred.
• You have familiarity with FDA EU MDR Health Canada Japan and other relevant international regulatory standards regulations and submission paths.
• You have a minimum of a Bachelors Degree (Required) in a Scientific or Technical discipline (Engineering Biology Biomedical Engineering Pharmacy Chemistry or similar)
• 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont stop until everybody everywhere has access to the quality of 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 Colorado Springs CO is $122000 to $194400
• The pay range for this position in San Diego CA Bedford MA and Cambridge MA is $137000 to $217728.
• The pay range for this position in Plymouth MN is $128000 to $204120

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.

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.

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 this position you must reside in or within commuting distance to Colorado Springs CO Cambridge MA San Diego CA and Plymouth MN
• May travel up to 10%

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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.