Regulatory Affairs Specialist

Regulatory Affairs Specialist

In this role you

Will establish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities

Your role:

Assists with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.

Advises product design teams on regulatory strategy and requirements for specific new products/solution.

Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations. Support both internal and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body.

Youre the right fit if:

Minimum of a Bachelor of Science degree in a technical, Quality, Regulatory or business discipline. MS desired.

Minimum of 1 years’ experience in FDA regulated Medical Device/Healthtech environments.

First line experience with US FDA, China NMPA and EU MDR is required. Knowledge of ISO 13485 and QSR requirements.

Experience with submission of Technical Documentation, 510K, and registrations of medical devices globally is preferred. Experience with Software as Medical Devices (SaMD) is 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.

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 role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we wont 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 WA and MA is $56,000 to $95,000, Annually.

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell WA or Cambridge MA.

#LI-PHI

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran