Regulatory Affairs Specialist I

Regulatory Affairs Specialist I 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 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. 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. Qualifications Minimum of 1+ years’ experience in Regulatory Affairs within FDA‑regulated Medical Device environments with exposure to 510(k)s, PMA supplements, EU MDR Technical Documents, and pre‑submissions. Knowledge of Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971) and experience with SaMD (IEC 82304) preferred. Familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths. Proficiency with Microsoft Office applications. Strong relationship‑building skills with internal and external stakeholders, sharing regulatory insights and ensuring alignment with regulatory requirements. Minimum of a Bachelor’s Degree in Regulatory Affairs, a scientific or technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry) or similar disciplines. Physical, Cognitive and Environmental Requirements You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. Benefits Competitive salary range based on location: Bedford, MA and San Diego, CA – $71,000 to $112,000; Plymouth, MN – $67,000 to $105,000; Colorado Springs, CO – $63,000 to $100,000. Other compensation may include an annual incentive bonus, sales commission or long‑term incentives. Employees are eligible for a comprehensive benefits program that includes generous PTO, 401(k) (up to 7% match), HSA, stock purchase plan, education reimbursement, and more. Equal Employment and Opportunity Statement Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. #J-18808-Ljbffr Philips International