Philips
Director of Regulatory, Software and Artificial Intelligence
Philips, Cambridge, Massachusetts, us, 02140
Director of Regulatory, Software and Artificial Intelligence
Join to apply for the
Director of Regulatory, Software and Artificial Intelligence
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Philips Director of Regulatory, Software and Artificial Intelligence
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Director of Regulatory, Software and Artificial Intelligence
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Philips Job Title Director of Regulatory, Software and Artificial Intelligence
Job Description
Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound) The Director, Regulatory Affairs-SW and AI will lead the regulatory strategy of all Software/Artificial Intelligence platforms for the Ultrasound business.
Your role: Lead a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for regulatory strategy development of new product introductions, maintaining clearances and product changes across the globe. Through end-to-end regulatory processes, ensure safe and effective products/solutions are brought to market, on time, and sustained throughout the life cycle via compliant, innovative regulatory strategies. Provide critical input on regulatory risk assessments to support portfolio selection. Build proactive, strategic relationships with external stakeholders (notified Bodies, U.S. FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations. Advise the regulatory and cross functional teams on the best communication and resolution strategies to address issues raised by government authorities during product reviews or audits Represent the regulatory affairs function within the Ultrasound Leadership Team. Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization. Responsible for the hiring and development of critical talent within the global regulatory affairs team through creating and sustaining robust development plans, ongoing coaching, and feedback, and identifying and addressing capabilities gaps.
You're the right fit if: You’ve acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with software-enabled medical devices, SaMD, AI, digital health, cloud computing, and associated development methodologies as well as lifecycle topics. You’ve acquired 5+ years of regulatory strategic leadership- with a strong track record in successfully leading a Regulatory Affairs team to bring products to market on time. Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Documentations/Design Dossier); Knowledge of MDD, MDR, MedDev & MDCG’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, and other applicable regulations, standards, and application of them. You have a bachelor’s degree or higher, in an Informatics or Engineering field 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 experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities); Experience in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
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 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 Plymouth, MN or Chicago, IL is $161,438 to $258.300.
The pay range for this position in Cambridge, MA, Washington D.C., or Bothell, WA is $172,200 to $275,520.
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.
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.
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Philips by 2x Sign in to set job alerts for “Director of Software” roles.
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Join to apply for the
Director of Regulatory, Software and Artificial Intelligence
role at
Philips Director of Regulatory, Software and Artificial Intelligence
1 week ago Be among the first 25 applicants Join to apply for the
Director of Regulatory, Software and Artificial Intelligence
role at
Philips Job Title Director of Regulatory, Software and Artificial Intelligence
Job Description
Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound) The Director, Regulatory Affairs-SW and AI will lead the regulatory strategy of all Software/Artificial Intelligence platforms for the Ultrasound business.
Your role: Lead a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for regulatory strategy development of new product introductions, maintaining clearances and product changes across the globe. Through end-to-end regulatory processes, ensure safe and effective products/solutions are brought to market, on time, and sustained throughout the life cycle via compliant, innovative regulatory strategies. Provide critical input on regulatory risk assessments to support portfolio selection. Build proactive, strategic relationships with external stakeholders (notified Bodies, U.S. FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations. Advise the regulatory and cross functional teams on the best communication and resolution strategies to address issues raised by government authorities during product reviews or audits Represent the regulatory affairs function within the Ultrasound Leadership Team. Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization. Responsible for the hiring and development of critical talent within the global regulatory affairs team through creating and sustaining robust development plans, ongoing coaching, and feedback, and identifying and addressing capabilities gaps.
You're the right fit if: You’ve acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with software-enabled medical devices, SaMD, AI, digital health, cloud computing, and associated development methodologies as well as lifecycle topics. You’ve acquired 5+ years of regulatory strategic leadership- with a strong track record in successfully leading a Regulatory Affairs team to bring products to market on time. Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Documentations/Design Dossier); Knowledge of MDD, MDR, MedDev & MDCG’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, and other applicable regulations, standards, and application of them. You have a bachelor’s degree or higher, in an Informatics or Engineering field 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 experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities); Experience in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
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 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 Plymouth, MN or Chicago, IL is $161,438 to $258.300.
The pay range for this position in Cambridge, MA, Washington D.C., or Bothell, WA is $172,200 to $275,520.
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.
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.
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Philips by 2x Sign in to set job alerts for “Director of Software” roles.
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