Job Title

Job Description

Provides legal advice and/or transaction support in a specialized (legal) area, in particular to group functions (such as M&A, Finance, Q&R, Compliance, IT, Procurement, Research) and management and provides second line of support to other legal colleagues supporting the Markets, BGs or Businesses.

Your role:

• Responsible for providing legal advice and support to help ensure that Philips products and facilities are compliant with the relevant laws, regulations and guidelines that are under the purview of the US FDA and other global medical device regulators. It will entail counseling Philips Quality and Regulatory, Business, and Market personnel as to the requirements they must meet in the development, marketing, and sales of medical devices under FDA and other applicable regulatory systems. The position will require advising quality and regulatory professionals, legal business partners, and management on: FDA submissions – pre-market notifications and pre-market approvals. Post-market requirements (e.g., adverse event reporting). FDA inspections and preparedness for such inspections at company facilities. Clinical investigations. Export issues under US and international laws.

• Develop and evaluate policies and procedures to ensure compliance with medical device regulations across Philips' businesses, collaborating with quality, regulatory, and business management teams.

• Serve as a resource for legal colleagues globally on medical device regulations, including contract review and potential regulatory implications.

• Coordinate responses to medical device enforcement actions, liaising with regulatory professionals, external counsel, and agencies like the FDA, while reviewing related media communications and supporting compliance training initiatives.

You're the right fit if:

• 8+ years of FDA compliance experience, with at least 5 years as an attorney, focusing on medical devices, including investigational devices, pre-market submissions, quality systems, device reporting, and advertising and promotion.

• Juris Doctor degree from an ABA accredited law school, or equivalent, and member in good standing of at least one U.S. state bar.

• Knowledge of the EU Medical Device Directive and regulatory frameworks in other major markets is essential. Proven experience collaborating with business leaders and regulatory professionals, either in-house or in private practice, is highly desirable.

• Ability to work effectively in a matrix organization alongside attorneys, paralegals, regulatory professionals, and business leaders.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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 role is an office 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 commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in Washington and Cambridge is: $182,000 to $270,000.

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.

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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/Disabled/Veteran and maintains a drug-free workplace.