Regulatory Affairs Specialist
| Company | Becton Dickinson |
|---|---|
| Location | Salt Lake City, UT, USA, Draper, UT, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Entry Level/New Grad, Junior |
Requirements
- Bachelor’s degree or higher, preferably in a scientific discipline
- 0-2 years’ experience; prior experience (including internships) in the medical device industry preferred (preferably in Regulatory Affairs or Quality)
Responsibilities
- Collaborates with Regulatory Affairs, Quality Assurance, and other associates on compliance support activities
- Understands fundamental global regulatory and quality system requirements
- Stays informed of new regulations and changes to existing regulations and communicates to management
- Monitors and analyzes regulatory information systems data; and coordinates actions to address issues
- Verifies product regulatory information to be submitted to global external databases
- Provides subject matter expertise on regulatory information systems to Regulatory Affairs team
- Provides regulatory support for internal and external quality system audits
- Supports development and implementation of corrective action plans for regulatory compliance findings
- Maintains FDA device listings and establishment registrations
- Writes and updates standard operating procedures (SOP), work instructions (WI), and policies and conducts internal training, as needed
- Conducts gap assessments of new and revised corporate procedures and external regulations and standards, and updates local documents accordingly
- Coordinates and responds to requests for product data and information
- Supports regulatory business processes
- Provides regulatory support for implementation of new systems and processes
Preferred Qualifications
- Excellent written and verbal communication skills
- Excellent problem solving and analytical skills
- Detail-oriented, with a focus on accuracy and completeness
- Excellent organization skills: able to manage multiple tasks and meet timeline commitments
- Ability to work in a team-oriented, fast-paced environment
- Desire to develop knowledge of global medical device regulations, with a focus on US and EU requirements
- Desire to develop knowledge of ISO 13485 and 21 CFR 820 quality system requirements
- Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)