Regulatory Affairs Specialist I

## Regulatory Affairs Specialist IApplylocations:
Bedford, Massachusetts, United States:
Colorado Springs, Colorado, United States:
San Diego, California, United States:
Plymouth, Minnesota, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
585246### Job Title Regulatory Affairs Specialist I###

Job Description 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.
** Your role:
*** 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.
** You're the right fit if:
*** You've acquired a 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.
* You have knowledge in Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971) and experience with SaMD (IEC 82304) is preferred.
* You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.
* You have Proficiency with Microsoft Office applications.
* You’re able to build strong relationships with internal/external stakeholders, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
* You have a minimum of a Bachelors’ Degree (Required) in Regulatory Affairs, a Scientific or Technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry) or similar disciplines.
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
** How we work together:
** We believe that we are better together than a part. 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.
** This is an
* Office-Based
* 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 of healthcare that we all deserve. Do the work of your life to help improve the lives of others.
* Learn more about our business.
* Discover our rich and exciting history.
* Learn more…