Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Carpinteria, CA
View more jobs in California

Job Details

Regulatory Affairs Associate

Carpinteria, CA

Apply for this job

4 hit(s)  


Regulatory Affairs Associate
Job SummaryThe NuSil Technology Regulatory Affairs department is seeking an experienced, detail-oriented individual with excellent critical thinking skills and the ability to understand and apply regulations and guidance documents across multiple industries. This position will assist with the management of global regulatory aspects of new product development and supply chain distribution including regulatory strategies and tactics and will prepare and submit documents necessary to gain US and foreign regulatory approval/clearance to place new or modified products into worldwide commercial distribution.
Job duties may include:
• Research and provide recommendations to product teams on appropriate regulatory pathways to market.• Review and approval of change orders, deviations, and corrective actions for product changes and/or modifications related to manufacturability and/or material modifications ensuring compliance with existing regulatory submissions.• Participation in design control, change control and risk management multi-disciplinary teams.• Participation as an integral member of product development and supply chain teams by providing expertise and making recommendations for regulatory direction. • Compilation of regulatory dossiers including Medical Device Master Files and Drug Master Files.
QualificationsA minimum of a Bachelor’s degree in science, biomedical engineering, medical/scientific writing, public health administration, legal studies or a related area is required. Excellent verbal and written communication skills and the ability to understand chemical manufacturing processes are required. Demonstrated attention to detail, strong organizational skills and the ability to work independently or in a team environment is required. Excellent working knowledge of domestic and international regulatory compliance requirements including ISO 13485, 21 CFR 210/211, 21 CFR 820, etc. 3-5 years of experience in regulatory affairs within the Medical Device or Pharmaceutical industries is desired. Experience in the preparation and submission of US FDA submissions is desired.
A minimum of a Bachelor's degree in science, biomedical engineering, medical/scientific writing, public health administration or a related area is required; An advanced degree in a technical, medical or business area is an asset; A minimum of 2 years of successful experience in a regulated healthcare environment (medical device, pharmaceutical, biologics) is required; Experience with domestic regulatory submissions is required; DMF, NDA, ANDA, 510(k) and/or PMA submissions experience is desired; Experience conducting regulatory activities in a clinical, regulatory, and/or quality or related area is required; Experience with international filing is an asset; Demonstrated understanding of Regulatory Affairs processes, both pre- and post-marketing is preferred; Excellent verbal and written communication skills required; Ability to work collaboratively in a team setting required.
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
EEO Statement
Avantor companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
This site is governed solely by applicable U.S. laws and governmental regulations. Use of this site constitutes your consent to application of such laws and regulations and our Privacy Policy.
Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.
Learn more at ****and ****Apply Now
Apply Now

Company info

Sign Up Now -

Similar Jobs:
Mgr Oversight Compliance, RN - CA PS9222
Location : Santa Barbara, CA
Mgr Oversight Compliance, RN - CA PS9222 in Santa Barbara California Mgr Oversight Compliance, RN - CA PS9222 New Location: Woodland Hills, California, United States Field: Medical Requisition #: PS9222 Post Date: 21 minutes ago...
Physician Contract & Compliance Specialist
Location : Santa Barbara, CA
Reports directly to the Chief Compliance Officer. This position is expected to perform complex and confidential duties to facilitate the review of physician contracts and compliance activities which include an understanding of gen...
I found a new job! Thanks for your help.
Thomas B - ,
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ComplianceCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ComplianceCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ComplianceCrossing - All rights reserved. 168