Regulatory Affairs Specialist

Job Title

Job Description

Regulatory Affairs Specialist

In this role you

This role is part of the global design and development teams supporting the Philips Oral Healthcare business unit which delivers power toothbrushes power flossers and whitening solutions innovations and product improvements to millions of customers worldwide. Our regulatory compliance group is located in USA Netherlands India China and Panama being primarily led from our primary development hub in Bothell Washington.

Your role:

• Assisting with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.
• Advising product design teams on regulatory strategy and requirements for specific new products/solution.
• Regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance. Review and approve engineering changes and labeling for regulatory compliance.
• Supporting the 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.
• Develops and facilitates regulatory submissions for new products/solutions existing products/ potential regulatory approval risks based on changes in regulations standards country specific issues or other unique characteristics of the project.

Youre the right fit if:

• You have a Bachelors or Masters degree in Chemistry Chemical Engineering Biomedical Engineering Business Administration Health Sciences Pharmaceutical Law or equivalent.
• 2 years with Bachelors OR Minimum 1 year with Masters of experience in regulatory affairs medical device and/or cosmetic product compliance quality compliance product stewardship chemical safety. Prefer 5 years of experience.
• You understand cosmetic formulation chemistry (emulsions surfactants preservatives actives) have knowledge of global cosmetic regulations (EU U.S. UK Canada China ASEAN) and strong analytical project management and stakeholder communication skills.
• RAPS RAC certification desired.

• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for thisOffice/Remoteposition.

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 companys facilities. Field roles are most effectively done outside of the companys 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 culture.

Philips Transparency Details

The pay range for this position in Bothell WA is $97440 to $136400 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.

#LI-PHI

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.