Job Title

　　Senior Regulatory Affairs Manager

　　Job Description

　　Sr. Regulatory Affairs Manager (U.S. work location based)

　　The Sr. Regulatory Affairs Manager for our MRI business will be the regulatory point of contact for the business and will work cross functionally with other groups to ensure proper compliance and alignment to relevant regulatory standards.

　　Your role: Serve as Regulatory Affairs lead on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams on boiler and pressure vessel code, ASME standards, EU-MDR, US FDA, Health Canada, and other global regulatory requirements for Super Conducting Magnets, Medical Devices and Systems. Coordinate the planning , preparation, assembly, review, and publication of regulatory submissions to regulatory authorities like Notified Bodies, FDA, and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Anticipate regulatory and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Maintain regulatory documentation to support compliance with regulatory requirements. Participate in internal and external audits. Fulfills selected Quality System requirements described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, and CAPA reviews). Maintain positive relationships with regulatory agencies and participate in executive committee and management meetings. You're the right fit if:

　　You've acquired 7 years of experience working with boilers and pressure vessels, super magnets industry preferred. Medical Device/Systems experience preferred. Experience in regulatory affairs, quality assurance, risk management, and process implementation/improvement preferred. Proven expertise in interacting with Competent Authorities, FDA, ISO, and other Regulatory Authorities.Your skills include a strong understanding of risk management requirements, tools, methodologies, and process including experience with ISO 14971. You have strong knowledge of appropriate regional and global regulations, requirements, and standards. Experience with ASME standards strongly preferred.You have a bachelors degree or higher in a related field. Masters degree preferred.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.You're an excellent communicator (written, and verbal), have strong analytical skills, and a demonstrated ability to manage complex projects and implement cultural change. Travel up to 20% annually, domestic/global possible.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. Read more about our employee benefits .If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .

　　Philips Transparency Details

　　The pay range for this position is $96,850 to $200,256, annually. The actual base pay offered may vary 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 Latham preferred, or other posted location .

　　Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.