- Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products
- Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy
- Responsible for regulatory planning for new product introductions and product changes, and ensuring maintenance of global regulatory compliance
- Responsible for product registration submissions/approvals as well as license renewals and updates for EU and further worldwide locations
- Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed
- Continuously analyze US, EU, and international regulatory requirements and initiate relevant design changes
- Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements
- Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations
- Provide Regulatory support for Audit, IIA and CAPA
- Other support as needed by the businessYou're the right fit if:US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor's degree or equivalent internationally acquired qualification preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- Medical device regulatory approvals and submittal experience across global markets
- Working knowledge of international and industry standards (i.e., ISO/IEC 60601 series, ISO 10993 series, etc.)
- Experience with evaluation of design, manufacturing, supplier changes paired with the ability to work cross functionally in a multinational organization
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with accuracy and a high attention to detail with minimal supervision.
- Excellent personal and intercultural skills that include:
- Solution and detail-oriented
- Well organized and self-motivated
- Team spirit and good communication skills
- Willingness and open for self-improvementAbout PhilipsWe 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.
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Regulatory Affairs Specialist - Seattle, United States - Philips
Description
Job TitleRegulatory Affairs SpecialistJob DescriptionLooking at the challenges the world is facing today Philips' purpose has never been more relevant.
So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
In this role you have the opportunity toEstablish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent AuthoritiesYour role: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 DetailsThe pay range for this position is $74,000,000 to $136,000, 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.
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 InformationUS 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.#LI-PHIThis 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.#J-18808-Ljbffr
