Regulatory Affairs Expert

Job Title

Regulatory Affairs Expert

Job Description

Exciting opportunity to be part of Philips Imaging Informatics regulatory team. Imaging Informatics

business unit includes solutions for radiology and cardiology. From enterprise imaging, PACS, and

workflow orchestration, through to a full suite of solutions for the cardiovascular workflow, we deliver

optimized imaging service lines that enable enterprise imaging across sites, specialties and technologies

to simplify medical image management, enable effective collaboration and enhance patient care. This role

will focus on radiology regulatory activities.

Responsibilities

• Represent regulatory affairs at the Radiology Informatics leadership team
• Through end-to-end regulatory processes, ensuring safe and effective products are brought to
  
  

market, on time, and sustained throughout life cycle via compliant, innovative regulatory

strategies

• Manage day-to-day functioning of radiology regulatory team ensuring effective and efficient
  
  

execution

• Provide critical input on regulatory risk assessments to support portfolio selection and post
  
  

market decision making

• Build proactive, strategic relationships with external stakeholders (Notified Bodies, 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.

• Lead and enable strong cross-functional partnership between regulatory affairs and all key
  
  

stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at

all levels within the business, and the local Regulatory Affairs teams in the Philips market

organization.

• Mentor and develop regulatory talent and competency to ensure strategic engagement and
  
  

execution excellence

Qualifications

• Bachelor’s degree (or equivalent), preferably in Informatics, engineering or life-sciences
• A minimum of 10+ years of experience working in Regulatory Affairs within a medical device company
  
  

industry.

• Experience with software enabled medical devices, SaMD, AI, digital health, cloud computing and associated development methodologies as well as lifecycle topics
  
  

Experience with radiology software devices with mature install base preferred

• Ability to work collaboratively with cross functional team and leadership to arrive at decisions
• Minimum of 3 years of functional management – with a strong track-record in successfully leading
  
  

a Regulatory Affairs team to bring products to market on time

• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier)
• Experience utilizing global regulatory policies, guidance and standards including FDA and EU
  
  

MDR expectation for radiology devices, QMS standards, safety risk management, software

development lifecycle, cybersecurity and labeling

• Experience with AI / ML enable device authorizations preferably in radiology settings
  
  

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.

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 the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
  
  

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 culture of impact with care here.