Regulatory Affairs Specialist I

About the role

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.

Responsibilities

• Support preparation, review, and maintenance of regulatory documentation for medical device products.
• Aid in 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.
• Aid 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.
• Maintain regulatory records, databases, and submission tracking tools.
• Participate in continuous improvement initiatives to enhance regulatory processes and compliance effectiveness.

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) and 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.
• Proficiency with Microsoft Office applications.
• Ability 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.

Qualifications

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Skills

• Strong understanding of medical device regulations and compliance.
• Excellent communication and collaboration skills.
• Ability to manage multiple tasks and deadlines.
• Experience with regulatory submission processes.
• Knowledge of regulatory standards and guidelines.

Benefits

• Comprehensive Philips Total Rewards benefits program, including a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

Pay

The pay range for this position in Bedford, MA and San Diego, CA is $71,000 to $112,000. The pay range for this position in Plymouth, MN is $67,000 to $105,000. The pay range for this position in Colorado Springs, CO is $63,000 to $100,000.

Schedule

This is an Office-Based role. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

Location

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. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA, Plymouth, MN, San Diego, CA or Colorado Springs, CO. May travel up to 10%.