Regulatory Affairs Specialist

Lumenis•San Jose, CA

About The Position

The Regulatory Affairs Specialist is a key partner to R&D, Quality, Manufacturing, and Marketing teams, responsible for driving regulatory strategy and ensuring compliance with global medical device regulations. This role leads cross-functional initiatives to achieve timely product approvals and market access, monitors regulatory changes, prepares & manages submissions, maintains compliance with applicable regulations & laws, liaison with regulatory agencies and supports continuous improvement across the regulatory function.

Requirements

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.

Nice To Haves

Experience with regulatory strategy development and interaction with regulatory authorities.
Knowledge of MDSAP and other global compliance frameworks.
Project management skills and ability to lead cross-functional initiatives.
Proficiency with documentation management and regulatory submission platforms.
Multicultural experience and language skills for international collaboration.

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)