Regulatory Affairs Specialist I

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 about our purpose. Learn more about our culture. Philips Transparency Details: 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. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here. Additional Information: 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% #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact View phone number on click.appcast.io, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights