Website Hopkins MedTech Compliance
The Hopkins MedTech Compliance helps medical device companies rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. HMC provides assistance in applying for EUA, premarket notice 510K by FDA, CE mark by European Commission and MDR.
A career at HMC will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
- Provides medical laboratory diagnostic and therapeutic information, products, and services.
- Develop and validate LDTs in accordance with established procedures and regulatory requirements.
- Lead LDT development projects, including coordinating with other team members, managing timelines, and ensuring quality control.
- Adheres to specimen preparation procedures.
- Implements new programs, tests, methods, and instrumentation.
- Establishes quality standards to maintain medical laboratory equipment performance.
- Keeps supplies stocked by determining inventory level.
- Maintains medical laboratory productivity by monitoring the workload of functional areas.
- Maintains laboratory staff by recruiting, selecting, orienting, and training employees.
- Completes operational requirements by scheduling and assigning employees.
- Ability and drive to solve practical problems
- Strong organizational skills
- Project management skills, including the ability to track and manage inventory
- Ability to read, analyze, and interpret general business inquiries
- Excellent multi-tasking skills
- Supervisory experience and strong leadership skills will be prioritized
- Excellent interpersonal, managerial, verbal and written communication skills
- Excellent critical thinking skills to be able to troubleshoot any issue with the processes and instrumentation
- Mandarin (Required)
- Have at least 2 years of laboratory training or experience, or both, in high-complexity testing
- Preference for direct analytical experience
- Preference for a Ph.D. degree in natural (chemical, or biological) sciences from an accredited college or university
Job Type: Full-time
Salary: $80,000.00 – $120,000.00 per year
- Health insurance
- Day shift
Supplemental pay types:
- Bonus pay
Please submit your resume and CV to email@example.com and mention that you saw this JD on the SAPA website.