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Verathon, Inc.
Bothell, WA, United States
Verathon, Inc. Senior Regulatory Affairs Specialist Bothell , Washington Apply Now Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, WA. As a key member of our team, you will play a crucial role in mana
Job Source: Verathon, Inc.Bio-Rad Laboratories
Seattle, WA, United States
As a Bio-Rad Regulatory Affairs Specialist III you will support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you'll apply your strong leadership skills and knowledge of regulatory requirements to ensure that our QMS and
Job Source: Bio-Rad LaboratoriesProclinical Staffing
Seattle, WA, United States
(Senior) Manager, Regulatory Affairs - Permanent - Seattle, WA Proclinical is seeking a (Senior) Manager, Regulatory Affairs for a global medical device company. This is a permanent role based at the company's manufacturing site in the Greater Seattle, WA Area. Primary Responsibilities: In this role, you will provide direct support to company ope
Job Source: Proclinical StaffingTerraPower
Bellevue, WA, United States
TITLE: Deputy and Senior Director, Regulatory Affairs LOCATION: Bellevue, WA, USA TerraPower is a nuclear technology company based in Bellevue, Washington. At its core, the company is working to raise living standards globally through a more affordable, secure, and environmentally friendly form of nuclear energy along with innovations in medical
Job Source: TerraPowerTerraPower
Bellevue, WA, United States
TITLE: Deputy and Senior Director, Regulatory Affairs LOCATION: Bellevue, WA, USA TerraPower is a nuclear technology company based in Bellevue, Washington. At its core, the company is working to raise living standards globally through a more affordable, secure, and environmentally friendly form of nuclear energy along with innovation
Job Source: TerraPowerFred Hutchinson Cancer Center
Seattle, WA, United States
Overview Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow t
Job Source: Fred Hutchinson Cancer CenterFred Hutchinson Cancer Center (Fred Hutch)
Seattle, WA, United States
Regulatory Affairs Associate Job ID 27719 Type Regular Full-Time Location US-WA-Seattle Category Clinical Research Support Services Overview Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred
Job Source: Fred Hutchinson Cancer Center (Fred Hutch)Fred Hutchinson Cancer Research Center
Seattle, WA, United States
Fred Hutch is proud to be an Equal Opportunity and VEVRAA Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation,
Job Source: Fred Hutchinson Cancer Research CenterBothell, WA, United States
Job Title Senior Regulatory Affairs Specialist Job Description Looking 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 to
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables.
Your role:
Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams.
Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Maintain regulatory documentations to support compliance with regulatory requirements.
Participants in internal and external Quality System Audits.
Fulfills selected Quality System requirements as described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).
Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
You'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.
You’ve acquired 5+ years of experience in medical device regulatory or quality assurance field
Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track record in obtaining FDA clearances and/or worldwide registrations, clinical trials and software development/regulatory submissions is a plus and authoring 510K’s.
You have a Bachelor’s degree in life sciences or a related field
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
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.
Read more about our employee benefits .
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 Details
The pay range for this position is $77,000,000 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 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.
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Email Alert for Senior Regulatory Affairs Specialist jobs in Bothell, WA, United States
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