**Sr. Regulatory Affairs Specialist** **In this role you** The Senior Regulatory Specialist will provide regulatory support for our Image Guided Therapy business including direct submission to health authorities and indirect project management of worldwide registrations. You will execute regulatory strategy to support the growth within the Structural Heart/Heart Rhythm Management category **Your role:** + Preparing comprehensive regulatory strategies for potentially complex new devices, and significant post market changes (such as line extensions, indication expansions, and substantive process/design changes). As necessary, reviews complex regulatory strategy issues with RA management. + Preparing regulatory filings for the US, EU, and Canada, potentially including FDA Pre-Submissions (and similar) for new products, as well as post-market changes. Maintain proficiency in worldwide regulatory requirements, particularly within US, EU, Canada, Japan, and China. + Following Philips' Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations. + Able to professionally negotiate and lead meetings (eg Pre-Subs) directly with regulatory agencies (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg Chief or Deputy) level. **You're the right fit if:** + Minimum of a bachelor’s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred. + Minimum of 5+ years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience. Prefer 2+ years of experience with SaMD. + Proficiency in understanding, interpretation and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. + Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentation and global registrations + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. **How we work together** We believe that we are better together than apart. 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 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 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 commitment to diversity and inclusion. **Philips Transparency Details** The pay range for this position in Plymouth is $75,000 to $130,000, Annually. 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. 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. **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 Plymouth, MN. \#LI-PHI It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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 888-367-7223, option 5, for assistance. Equal Employment and Opportunity Employer/Disabled/Veteran