Senior Regulatory Affairs Specialist
Proclinical is currently recruiting for a Senior Regulatory Affairs Specialist for a biotechnology company located in Redwood City, CA. Successful candidate will be responsible for the coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines and standards.
- Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support products, marketing applications and post-market activities.
- Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines.
- Prepare Memo to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals.
- Prepare and maintain Technical Files for Europe (CE Mark) for new products, new indications, and significant product changes.
- Support product development teams on regulatory issues, including review of documentation.
- Provide regulatory assessments for anticipated design, manufacturing and labeling changes.
- Represent RA functional area in the review and approval of Engineering Change Orders (ECO).
- Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials.
- Perform regulatory research and stay abreast of changes for US and international regulations and requirements.
- Provide regulatory support for quality assurance and regulatory compliance activities as required.
- Maintain well-organized, auditable regulatory files.
Skills and Requirements:
- BS in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred.
- 4+ years' experience in regulatory affairs with direct project management responsibilities.
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299) is required.
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required.
- Experience with Quality Management System Standard ISO 13485 is required.
- Experience with Risk Management Standard ISO 14971 is required.
- Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred.
- Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat.
- Strong organization skills, able to manage multiple projects and timelines.
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation.
- Excellent oral and written communication skills.
- Strong attention to detail.
- Ability to work independently as an individual contributor and in a team environment.
- Knowledge of software development and software quality as it relates to regulatory submissions a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 415-660-4945 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.