Top Regulatory Affairs Executive jobs in Washington
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Regulatory Affairs Associate II
- InBios International, Inc.
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Seattle, WA
FULL_TIME
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Description
Are you a problem-solver? A collaborator? Ready to tackle the world of infectious diseases? InBios is looking for people who value a sense of community, cooperation and camaraderie with a shared vision of delivering impactful solutions to those affected by infectious diseases. At InBios, your ideas are valued, your voice is heard, your accomplishments are celebrated.
About Inbios
InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios is dedicated to delivering superior quality products that are accurate, easy to use and cost effective. We have a portfolio of more than 25 diagnostic products, as well as an extensive catalog of life science reagents. For more information, visit www.inbios.com.
Our primary location is in the dynamic neighborhood of South Lake Union in a state-of-the-art biotech facility, and our secondary location is in the SODO neighborhood with newly remodeled lab and office space in an historic building next to Lumen Field. InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.
About You
We are seeking a mindful and diligent individual with experience in all aspects of regulatory affairs as it pertains to in-vitro diagnostic products. A solid understanding of immunoassays is required as well as molecular assays and associated FDA regulations. The ability to keep abreast with the ever-changing FDA and international regulations to position product for domestic and international marketing is key. If you enjoy leading and collaborating on projects, performing a variety of tasks, and working with the FDA and other regulatory bodies, and being part of a reliable and dedicated Regulatory Affairs team, then we encourage you to apply for this position.
Experience and knowledge needed to be successful in this position:- BS/MS in life sciences or bioengineering, and at least 5 years of experience in an FDA-regulated IVD manufacturing company or a Ph.D. with 2 years of experience.
- Certification in regulatory affairs preferred.
- Excellent knowledge of US and international IVD regulations.
- Strong written and verbal communication skills.
- High attention to detail.
- Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).
- Ability to manage multiple projects and deadlines.
- Strong understanding of statistical analysis.
- Ability to identify compliance risks and escalate when necessary.
- Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays is required.
- Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
- Write/review protocols for analytical studies in support of regulatory submissions.
- Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
- Support international registrations, create and maintain technical files, and prepare product dossiers.
- Prepare and maintain Design History Files.
- Lead Risk Management effort.
- Prepare and review labeling and marketing materials to ensure regulatory compliance.
- Help set the regulatory strategy for new product development.
- Keep abreast with the latest regulatory requirements and trends.
- Communicate with the FDA and other regulatory bodies concerning product submissions.
- This is an on-site office position which requires an ability to sit and work at a computer for long periods during the workday.
- This position includes some work that takes place in a BSL-2 laboratory and a humidity-controlled room.
Salary Range (annually): $90,000 - $125,000
Employees (and their families) are able to enroll in medical, dental, vision, and voluntary life insurance. Employees are covered by basic life insurance and long-term disability insurance. Employees are able to enroll in our company's 401k and/or Roth IRA retirement savings plans and Flexible Savings Account (FSA). Employees accrue 2-weeks of paid vacation per year and a total of eleven paid holidays throughout the year, which includes the holiday observance of winter break at year end (the workdays between Christmas Day and New Year's Day). - Just Posted
Regulatory Affairs Associate
- Fred Hutchinson Cancer Center
-
Seattle, WA
FULL_TIME
- 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 Seattl...
- 1 Day Ago
Director Regulatory Affairs, CMC
- Immunome, Inc.
-
Bothell, WA
FULL_TIME
- DescriptionJob Title: Director Regulatory Affairs, CMCLocation: BothellAbout Us: Immunome is a clinical stage biotechnology company headquartered in Bothell, WA dedicated to developing first-in-class ...
- 4 Days Ago
Sr. Regulatory Affairs Specialist
- Bruker
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Bothell, WA
FULL_TIME
- Sr. Regulatory Affairs Specialist Job Locations US-WA-Bothell | US-WA-Seattle ID 2024-16333 # of Openings 1 Job Function Quality & Regulatory Overview The Senior, Regulatory Affairs Specialist is resp...
- 10 Days Ago
Regulatory Affairs Associate, Senior
- Fred Hutchinson Cancer Center
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Seattle, WA
FULL_TIME
- 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 Seattl...
- 15 Days Ago
Regulatory Affairs Consultant II
- iTech Solutions
-
Bothell, WA
CONTRACTOR
- Experience: Minimum 2-5 years professional experience in the applicable role. Education: Bachelor's degree or equivalent. Supports product safety, compliance and regulatory function (SCR) performing t...
- 15 Days Ago
Top Regulatory Affairs Executive jobs at Popular Companies
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/2/2024 12:00:00 AM
Regulatory Affairs Specialist
- ProKatchers LLC
-
Andover, MA
- Job Summary: include specific internal and external relationships, product focus, regulatory requirements, physical dema...
- 6/2/2024 12:00:00 AM
Regulatory Affairs Specialist
- Idaho State Job Bank
-
Boise, ID
- Regulatory Affairs Specialist at J&J Family of Companies in Boise, Idaho, United States Job Description Regulatory Affai...
- 6/2/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/1/2024 12:00:00 AM
Principal Regulatory Affairs Specialist
- MicroVention-Terumo
-
Aliso Viejo, CA
- Working for a company voted Great Places to Work - 2022, the Principal, Regulatory Affairs Specialist is responsible for...
- 5/31/2024 12:00:00 AM
Regulatory Affairs Specialist
- TalentBurst, an Inc 5000 company
-
Fort Worth, TX
- Position: Regulatory Affairs Specialist III, Req#: 2797-1 Location: Fort Worth, TX (100% Onsite) Duration: 6+ Months Con...
- 5/31/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
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- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 5/29/2024 12:00:00 AM
Sr. Specialist, Regulatory Affairs
- Alphatec Spine
-
Carlsbad, CA
- The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and interna...
- 5/29/2024 12:00:00 AM
About Washington
Washington (/ˈwɒʃɪŋtən/), officially the State of Washington, is a state in the Pacific Northwest region of the United States. Washington is the northwestern-most state of the contiguous United States. It borders Idaho to the east, bounded mostly by the meridian running north from the confluence of the Snake River and Clearwater River (about 116°57' west), except for the southernmost section where the border follows the Snake River. Oregon is to the south, with the Columbia River forming the western part and the 46th parallel forming the eastern part of the Oregon-Washington border. To the wes...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$316,561 to $517,900
Most Popular Cities in Washington for Top Regulatory Affairs Executive Jobs
What does a Top Regulatory Affairs Executive do?
Top Regulatory Affairs Executive in Wilmington, NC
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If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
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During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
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