Job Title

Sr Regulatory Operation Specialist

Job Description

Job Summary

We are seeking an experienced Senior Regulatory Affairs Operation Specialist with deep expertise in Software as a Medical Device (SaMD) to lead and support global regulatory activities. This role is responsible for driving international product registrations, managing regulatory databases, ensuring compliance with global standards, and supporting end-to-end submission strategies for software-driven medical technologies.

The ideal candidate will have strong knowledge of global regulatory frameworks, SaMD standards, and proven experience managing complex regulatory submissions across multiple geographies.

Job Title: Sr Regulatory Operation Specialist

Key Responsibilities

Regulatory Strategy & Submissions

• Lead and support international regulatory submissions for SaMD and medical device products (US, EU, Canada, and other global markets)

• Support regulatory strategy development for product lifecycle activities, including new registrations, renewals, and change management

Regulatory Operations & Systems

• Manage and maintain regulatory data in systems such as RIMSYS, SAP, and other regulatory databases

• Ensure accurate tracking of registration and licensing status across regions

• Maintain regulatory repositories including Declaration of Conformity, LTFs, 510(k)s, and Technical Documentation

• Support UDI, GUDID, EUDAMED, and establishment registration activities

Product Change & Lifecycle Management

• Initiate and manage Product Change Notices (PCNs) in collaboration with Business Units and Regulatory stakeholders

• Assess regulatory impact of product/software changes and ensure timely submissions/notifications

• Maintain dashboards to track change implementation and regulatory status

Labeling & Compliance

• Initiate and manage labeling change requests and ensure compliance with local and international requirements

• Coordinate with R&D and Quality teams for timely label updates and releases

• Monitor implementation timelines and communicate status to stakeholders regularly

Standards & Compliance

• Ensure compliance with applicable standards including IEC 62304 (software lifecycle), IEC 62366 (usability), and IEC 60601-1 (as applicable)

• Stay current with evolving regulations related to SaMD, cybersecurity, AI/ML, and cloud-based medical software

• Provide regulatory guidance on software validation, risk classification, and clinical evaluation

Data Analytics & Reporting

• Develop and maintain dashboards and reports using tools like Power BI and Power Automate

• Provide insights on regulatory metrics, submission timelines, and compliance status

• Support gap assessments and continuous improvement initiatives

Documentation & Knowledge Management

• Develop, review, and maintain high-quality regulatory documentation

• Collaborate with SMEs to gather technical content for submissions

• Establish standardized templates and documentation frameworks

• Support centralized documentation repositories and data migration strategies

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field

• 10+ years of experience in Regulatory Affairs within the medical device industry

• Strong experience with Software as a Medical Device (SaMD) regulatory submissions

• Proven expertise in global regulatory frameworks (FDA, EU MDR, Health Canada, etc.)

• In-depth knowledge of IEC 62304, IEC 62366, and relevant medical device standards

• Experience with regulatory information management systems (e.g., RIMSYS)

Preferred Qualifications

• RAPS Regulatory Affairs Certification (RAC)

• Experience with AI/ML-based medical devices and associated regulatory pathways

• Knowledge of cybersecurity and cloud regulations for medical devices

• Familiarity with quality management systems and product lifecycle processes

Key Skills & Competencies

• Regulatory strategy and submission expertise

• Strong analytical and data management skills

• Advanced proficiency in Microsoft Office 365 tools (Excel, Power BI, Power Automate)

• Excellent documentation and technical writing skills

• Stakeholder management and cross-functional collaboration

• Attention to detail with a “first-time-right” mindset

• Ability to work independently and drive process improvements

Work Environment & Impact

• Works under general direction with a high degree of independence

• Influences regulatory outcomes for global product launches

• Collaborates across global teams and regulatory bodies

• Contributes to compliance, innovation, and patient safety through effective regulatory practices

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.
Indicate if this role is an office/field/onsite 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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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 culture of impact with care here.

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