Director or Regulatory, Software and Artificial Intelligence

Job Title

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 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.

#LI-PH1

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.