Regulatory Affairs Specialist I

Philips•San Diego, CA

3d•$63,000 - $112,000•Onsite

About The Position

The Regulatory Affairs Specialist I supports regulatory activities to help ensure Philips Image Guided Therapy Devices are safe, effective, and compliant with applicable global regulatory requirements. This role also provides an excellent opportunity to develop expertise in medical device regulations, including FDA regulations, EU MDR requirements, and international regulatory processes.

Requirements

Minimum of 1+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments with experience/exposure to 510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions.
Knowledge in Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971).
Proficiency with Microsoft Office applications.
Able to build strong relationships with internal/external stakeholders, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
Minimum of a Bachelors’ Degree (Required) in Regulatory Affairs, a Scientific or Technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry) or similar disciplines.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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.
For this position, you must reside in or within commuting distance to Bedford, MA, Plymouth, MN, San Diego, CA or Colorado Springs, CO.

Nice To Haves

Experience with SaMD (IEC 82304) is preferred.
Familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.

Responsibilities

Support preparation, review, and maintenance of regulatory documentation for medical device products.
Assist with regulatory submissions, registrations, renewals, and product change assessments under the guidance of senior regulatory professionals.
Contribute to the development and maintenance of Technical Documentation and Design History Files to support regulatory compliance.
Research and interpret regulatory requirements, standards, guidance documents, and industry best practices.
Partner with cross-functional teams including Quality, R&D, Clinical, Marketing, Manufacturing, and Supply Chain to ensure regulatory requirements are understood and implemented.
Support regulatory activities throughout the product lifecycle, including product development, design changes, and post-market surveillance.
Assist in preparing responses to regulatory authority requests and audit observations.
Participate in internal audits, quality management system activities, and inspections as needed.
Support international market registrations and regulatory compliance activities for regions such as the United States, European Union, Canada, Japan, and other global markets.
Monitor regulatory changes and communicate relevant updates to internal stakeholders.
Help maintain regulatory records, databases, and submission tracking tools.
Participate in continuous improvement initiatives to enhance regulatory processes and compliance effectiveness.