Regulatory Affairs Intern –Regulatory Operations Team
12-week Internship, ArcherDX Inc, Boulder, CO
ArcherDX Inc, (“Archer”) is seeking to fill an internship for its growing Regulatory Operations group. The primary focuses of this position will be supporting quality system document development, regulatory process improvement/creation, and labeling support.
Ideal Candidate Characteristics
- Strong desire to be part of a dynamic, growing, and mission driven company
- Driven to thrive in a rapidly changing, fast-paced environment
- Ability to organize a plan and work with an interdisciplinary team, as well as work independently to meet project deadlines
- Excellent ability to multi-task and manage multiple priorities.
- Strong critical thinking skills
- Excellent communication and writing skills
- Demonstrated interest in regulatory affairs in drug, medical device, or IVD sectors
- Familiarity with quality systems, technical writing, and formalized governmental interaction
- With direction from the regulatory team, draft procedures, forms and templates in support of Regulatory Ops initiatives
- Participate in gap assessments for international standards
- Assist with labeling verification and traceability
- Organize regulatory document archiving in both physical and electronic media
- Analyze guidance documents, international standards and applicable law for relevance to Archer products to provide guidance for project teams
Job Requirements and Qualifications
- Minimum of junior level in pursuit of a Bachelor’s degree, with preference for those in a scientific discipline
- Proficiency with Microsoft Office and Adobe Pro
- Strong writing skills with an acute attention to detail
- Familiar with testing and documentation methodologies
- Excellent verbal and written communicator
Please provide a detailed cover letter describing why a regulatory affairs position, in particular, is attractive to you.