Biologics & Medical Device Consulting Group, Inc. is a privately held regulatory, clinical and quality consulting group. We are seeking to hire, on a contract basis, an entry level regulatory affairs associate 1 (RA-1). As an RA-1 you will be part of a small elite team that is dedicated to bringing ethical, cutting-edge therapies (medical devices, biologics and pharmaceuticals) that improve patients’ lives to market.
Collaborate with regulatory and clinical professionals to support regulatory submissions and approvals including, but not limited to, Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE), 510(k)s, de novos, PMAs, annual reports, supplements, New Drug Applications (NDAs), Biologics License Applications (BLAs), and Clinical Study Reports (CSRs)
Contribute to the preparation of responses to regulatory agency inquiries and requests for additional information
Collaborate with subject matter experts and cross-functional teams to gather and interpret data and information necessary for regulatory submissions
Ensure that all regulatory documents are accurate, well-organized, and comply with regulatory guidelines
Assist in the development and maintenance of document templates, style guides, and best practices for regulatory writing
Bachelor's degree in a scientific, medical, or related engineering field; advanced degree (e.g., Master's or Ph.D.) a plus. Depending on education level, 1-3 years experience in regulatory affairs
Excellent writing, editing, and proofreading skills, with a keen eye for detail and clarity
Proficiency in interpreting and summarizing complex scientific and clinical data
Ability to work independently, meet deadlines, and manage multiple projects simultaneously
Familiarity with regulatory guidelines and requirements for device, drug and / or biologic product development
Strong project management and organizational skills
Proficiency in Microsoft Office Word and Excel
What we offer:
Competitive hourly rate.
Embrace flexibility and remote opportunities with a contract-based engagement.
Opportunities for professional growth and development.
A collaborative and innovative work environment.
Telecommuting permitted, but must be willing to travel to client sites (up to 5% travel)
About Biologics & Medical Device Consulting Group, Inc.
BioMDg is a unique consulting group comprised of a core team of Preclinical, Clinical, Regulatory and Marketing professionals closely aligned with a network of experts with proven track records in multiple areas of science, medicine and new technology marketing. We use a global comprehensive approach to bring products to market early.