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.
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.
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
**MEMBERS ONLY**SIGN UP NOW***.
**MEMBERS ONLY**SIGN UP NOW***. Jobs