Senior Regulatory Affairs Specialist

### Job TitleSenior Regulatory Affairs Specialist### Job Description**Senior Regulatory Affairs Specialist, Ultrasound**The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA, and offering strategic guidance on clinical studies and evaluations.**Your role:*** Act as an ambassador of Philips values and ensure compliance with all relevant business processes and regulatory procedures.* Serve as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies.* Coordinate and prepare documentation for regulatory submissions—such as Product Reports, Technical Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.* Support cross-functional teams with regulatory expertise during the design and development phases for new products and major changes to existing products.* Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.**You're the right fit if:*** You’ve acquired 5+ years of experience in medical device regulatory affairs, with 510(k), and EU MDR Technical Documentation authoring experience required. Experience with SaMD or SiMD submissions is strongly preferred. International submissions experience is a plus.* You have strong understanding of relevant regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable regulations and standards related to software medical devices is preferred. Experience with software development life cycle, artificial intelligence, data science, and/or software testing is preferred.* You have a Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline. RAPS certification is a plus.* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .* You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your regulatory expertise. You are willing and able to travel up to 10% based on business needs.**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-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 healthcare that we all deserve. Do the work of your life to help improve the lives of others.* **Learn more about** **.*** **Discover*** **Learn more about*** **Learn more about****Philips Transparency Details**The pay range for this position in Murrysville, PA is 94,000 to $150,000.The pay range for this position in Plymouth, MN is $99,000 to $157,000.The pay range for this position in Cambridge, MA, Washington D.C., or Bothell, WA is $105,000 to $168,000.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 .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 one of the posted locations.#LI-PH1This 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.* #J-18808-Ljbffr