Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
Our goal is to improve lives by restoring or replacing the function of damaged cells tissues and organs for patients. BioFabUSAs mission is to develop a highly diverse competitive capable and innovative cell tissue and organ ecosystem that ensures a lowcost and highquality domestic healthcare system and domestic leadership in the biofabrication industrial base.
The Impact That You Will Make
Senior Regulatory Affairs Consultants are critical to our success. In this role you will contribute to a strong Regulatory team devising robust regulatory strategies for ARMI members and internal projects while ensuring compliance to federal regulations. Products include complex biologics devices and combination products with many in the preclinical and clinical spaces. This position reports to the Director of RA/QA.
Your Role
- Attend meetings and teleconferences with clients seeking strategic regulatory guidance
- Provide expertise related to regulatory strategy preclinical and clinical study design CMC and other topics
- Draft and review FDA meeting request packages; attend FDA teleconferences
- Contribute to the planning development organization writing and editing of regulatory applications for BioFabConsulting members/clients
- Provide guidance and mentorship to more junior regulatory staff
- Create original regulatory education materials such as workshop content and web pages
- Provide input and assistance on ARMI BioFabUSA projects in the technical education and workforce development and membership areas on an asneeded basis
- Continually bolster personal knowledge by studying trends and developments in regulatory affairs participating in educational opportunities reading professional publications maintaining personal networks and participating in professional organizations
- Attend events workshops and meetings organized by ARMI BioFabUSA or by ARMI members
Your Skills and Experiences
- B.S. or B.A. degree required; degree in life sciences or engineering is preferred
- Minimum of 8 years of direct work experience in human medical product regulatory affairs; experience with biologics preferred
- Thorough knowledge of U.S. FDA medical product regulations current industry practices and experience with interpretation and application of said regulations and practices
- Ability to influence colleagues clients and Institute members at all levels in the organization
- Exceptional written and verbal communication skills
- Proficient with Microsoft software products
- Ability to multitask meet deadlines and set priorities
- Ability to work independently and thrive in a fastpaced rapidly changing environment
- Collaborative attitude sense of curiosity and eagerness to impact positive change
Required Experience:
Senior IC
Employment Type
Full-Time
