Regulatory Affairs Specialist

Philips•Bothell, WA

29d•Onsite

About The Position

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/solutions. Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project. You're the right fit if: You have a Bachelor's or Master's degree in Chemistry, Chemical Engineering, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. 2+ years with Bachelor's OR Minimum 1 year with Master's 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 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 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 culture. Philips Transparency Details The pay range for this position in Bothell WA is $97,440 to $136,400 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.

Requirements

Bachelor's or Master's degree in Chemistry, Chemical Engineering, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
2+ years with Bachelor's OR Minimum 1 year with Master's of experience in regulatory affairs, medical device and/or cosmetic product compliance, quality compliance, product stewardship, chemical safety.
You understand cosmetic formulation chemistry (emulsions, surfactants, preservatives, actives)
have knowledge of global cosmetic regulations (EU, U.S., UK, Canada, China, ASEAN)
strong analytical, project management, and stakeholder communication skills.
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.
US work authorization is a precondition of employment.

Nice To Haves

Prefer 5+ years of experience.
RAPS RAC certification desired.

Responsibilities

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/solutions.
Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.