Director of Regulatory Affairs - Software & Systems
Location
Cambridge, MA | United States
Job description
JOB DESCRIPTION
Job Title
Director of Regulatory Affairs - Software & Systems
Job Description
The Director of Regulatory Affairs-Software & Systems will play a critical role in ensuring Philips Software driven devices and systems are safe, reliable, and compliant, through gaining global market authorization for software enabled solutions and play a key role in building regulatory capabilities in the areas of software, cloud computing and artificial intelligence.
Your role:
- Responsible for Strategic Regulatory leadership and the development of regulatory strategies, detailed regulatory plans and submissions.
- Execute pre-market and post-market regulatory activities as per applicable procedures in I&S, IP&S and business units as assigned. This position will support software enabled medical devices with focus on major markets including the US and EU.
- Proactively provide clear regulatory inputs, guidance and deliverables for new product introductions and product changes.
- Provide clear and timely interpretation of global regulations that are actionable for assigned projects.
- Represent regulatory in key activities including Quality Management Reviews, risk management, design reviews, portfolio selection process, change management, adoptions of new guidance / standards, post-market activities, audits, inspections.
- Support audits, inspections, and surveillance visits by regulatory agencies and Notified Body as a regulatory representative.
- Actively participate in regulatory skill development and knowledge sharing.
- Reporting to the Head of Regulatory Affairs-Enterprise Informatics/Innovation & Strategy you will partner with stakeholders in the Innovation & Strategy (I&S), Intellectual Property & Standards (IP&S) as well as other Philips business units to gain global market authorization for software enabled solutions. You will Interact with internal/external stakeholders, including regulatory authorities/development partners and lead/enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions.
- This Hybrid role may require travel up to 15%.
You're the right fit if:
- You’ve acquired a minimum of minimum of 10 years’ experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) environments (required), with a minimum of 3 years’ experience in functional/strategic leadership.
- You have experience with regulatory requirements for AI, algorithms, data science, cloud computing and interoperability highly preferred. Experience with wearable medical devices-(ECG, PPG, or similar) highly desired.
- You’ve acquired extensive experience and knowledge of global medical device regulations, guidance, and applicable standards. Experience with FDA’s pre-submission and submissions (510(k)s, De Novo, 513(g) etc.), EU MDR process, Technical Documentation preparation and associated guidance, standards.
- You have expertise in software specific regulatory guidance, standards including (not limited to) software (IEC 62304/82304) / device lifecycle management, risk management (ISO 14971), cybersecurity, human factors (IEC 62366), clinical and bench top testing.
- You’re able to efficiently review typical device development artifacts, DHF documents and provide guidance / feedback to cross functional team to enable the development of safe, effective, and high-quality products.
- You have the ability to review clinical study plans, reports, and statistical analysis artifacts for use in device regulatory submissions.
- You have a proven track record of working effectively with cross-functional teams and working in a matrix organization (a plus).
- You’re well versed in methodologies (lean, agile) and associated tools for software development.
- You acquired extensive experience in managing strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities, development partners).
- You have a minimum of a Master's degree (Required) in Engineering, Regulatory Affairs, Life Sciences or similar disciplines.
- You’re able to communicate, influence and build relationships with Internal/External Stakeholders at all levels.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
- 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.
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 $137,000 to $236,000, 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.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Job tags
Salary
