Principal Regulatory Affairs Specialist (U.S. Hub based)Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical decision support software medical device (SaMD) that uses patented “smart rules” to deliver actionable alerts to clinicians that can be predictive of patient deterioration. This role is critical for launching Surveillance worldwide and provides the opportunity to work closely with Clinical Affairs, Product Management and R&D to ensure its success.Your role:
Ensure that products comply with all the relevant safety, regulatory and quality policies and regulations in the Clinical Integration and Insights (CII) business unit.
Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and product changes across the globe.
Ensure products are brought to market on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.
Provide critical input on regulatory risk assessments to support portfolio selection.
Collaborate proactively and establish strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access with the current portfolio in connection with future innovations.
Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the business, and the local RA teams in the Philips international markets organization.
Build regulatory submissions strategy for the products portfolio, providing related guidance to cross-functional dedicated team and authoring regulatory submissions.
Establish and provide tactical alignment across CII on regulatory aspects of state of the art- standards’ implementation.
Provide guidance to CII on regulatory aspects of UDI (unique device identification) and implementation.
Facilitate updates to regulatory body (FDA, Health Canada, EUDAMED, etc.) registrations and device listings.
Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance. Update CII regulatory procedures when new regulatory requirements become effective.
Provide regulatory support and follow-up for QMS audits.
Review and approve marketing, advertising, promotional items and labeling for regulatory compliance.
You're the right fit if:
You’ve acquired 7+ years of experience in Regulatory Affairs in the medical device industry. SaMD experience and extensive EUMDR experience are required. Experience authoring 510(K) and Health Canada submissions required, as well as other global submissions. Strong experience with strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities)
Your skills include extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.).
You have a bachelor’s degree (Master’s/PhD preferred) in a science related field.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) position.
You’re an excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes. You have an ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. You are self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.
About PhilipsWe 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.
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Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
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Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe 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 (https://www.careers.philips.com/na/en/best-employee-benefits) .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 InformationUS 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 the posted location.#LI-PH1It 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