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Lumenis · 7 hours ago

Regulatory Affairs Specialist

San Jose, CA

Full-time

Onsite

Senior Level

5+ years exp

Lumenis is a company focused on medical innovation, and they are seeking a Regulatory Affairs Specialist to drive regulatory strategy and ensure compliance with global medical device regulations. The role involves collaboration with various teams to achieve product approvals and maintain adherence to regulatory standards.

BiotechnologyHealth CareMedical

Responsibilities

Develop regulatory strategies for new product introductions and significant changes to existing devices aligned with business objectives

Prepare, review, and submit regulatory documentation for Class II/III medical devices in accordance with FDA, EU MDR, Health Canada, APAC, Latin America and other regions

Ensure adherence to ISO 13485, EU MDR 2017/745, IEC 60601 standards, other international requirements, and internal quality procedures

Maintain documentation for audits and inspections

Collaborate and lead cross-functional regulatory projects with R&D, Marketing, Quality, and Manufacturing teams to ensure regulatory compliance during design control, risk analysis, verification & validation and release of documentation into documentation management system while managing timelines

Support risk management (with cybersecurity risks) technical documentation and clinical evaluation requirements

Monitor changes in global regulations, assess impact on products and provide guidance to internal stakeholders

Support mitigation plans for regulatory risks

Serve as the primary regulatory liaison with the regulatory authorities and internal stakeholders

Foster a culture of collaboration, process improvement and regulatory intelligence

Promote best practices and continuous improvement with the regulatory function

Establish and track performance metrics for regulatory activities (e.g. timely submissions and track approvals globally)

Qualification

Regulatory strategyGlobal submissionsISO 13485FDA QSRClass II/III devicesRisk managementDocumentation managementProject managementAnalytical skillsCommunication skillsProblem-solving skillsInterpersonal skills

Required

Bachelor's degree in life sciences or engineering discipline or related field (advanced degree preferred)

Minimum 5–7 years in regulatory affairs for medical devices, with proven expertise in global submissions and regulatory strategy (FDA, EU MDR, Health Canada, Latin America and APAC regions)

Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), EU MDR 2017/745, IEC 60601, and related standards

Direct experience with Class II/III devices; energy-emitting devices a plus

Familiarity with technical documentation, risk management, and clinical evaluation requirements

Excellent organizational, analytical, and problem-solving skills

Strong interpersonal, communication skills, negotiation and stakeholder management abilities to influence and collaborate across functions

Ability to manage multiple projects in a fast-paced environment