Regulatory Affairs Expert

Philips
Israel
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: bachelorsSkills: ["Leadership","Collaboration","Communication","Stakeholder management","Strategic thinking"]

Lead regulatory activities for Philips Imaging Informatics in radiology, coordinating with Notified Bodies, FDA and authorities to ensure safe, compliant, timely market access. Manage day-to-day regulatory operations, mentor the team, and build proactive relationships with external stakeholders to enable lifecycle management and future innovations.

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Philips
Philips
3 months ago

Regulatory Affairs Expert

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Last checked: 14 hours agoStatus: Live

Job Summary

Lead regulatory activities for Philips Imaging Informatics in radiology, coordinating with Notified Bodies, FDA and authorities to ensure safe, compliant, timely market access. Manage day-to-day regulatory operations, mentor the team, and build proactive relationships with external stakeholders to enable lifecycle management and future innovations.
Location: Israel
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Represent regulatory affairs at the Radiology Informatics leadership team
  • •Through end-to-end regulatory processes, ensuring safe and effective products are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies
  • •Manage day-to-day functioning of radiology regulatory team ensuring effective and efficient execution
  • •Provide critical input on regulatory risk assessments to support portfolio selection and post market decision making
  • •Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations.

Key Requirements

  • •Bachelor’s degree (or equivalent), preferably in Informatics, engineering or life-sciences
  • •Minimum of 10+ years of experience working in Regulatory Affairs within a medical device company
  • •Experience with software enabled medical devices, SaMD, AI, digital health, cloud computing and associated development methodologies as well as lifecycle topics
  • •Minimum of 3 years of functional management – with a strong track-record in successfully leading a Regulatory Affairs team to bring products to market on time
  • •Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier)
Experience:10+ yearsMedical devicesRadiologyHealthcare
Education:Bachelor's
Skills:LeadershipCollaborationCommunicationStakeholder managementStrategic thinking
Languages:English
Tech Stack:AICloud computingSaMD

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn