What are the responsibilities and job description for the Regulatory Compliance Manager position at Bolt Medical?
Qualifications:
To be successful in this role, you will need:
- Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
- Minimum 5 years of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.
- Experience in catheter design and production, or with similar medical devices, while working within Quality is required.
- GMP experience working within ISO 13485, ISO 14976 and FDA 21 CFR Part 820 environments.
- Capable of reviewing and interpreting drawings.
- Experience in Risk Management Records and Risk Analysis.
- Experience in performing test method validation and Gage R&Rs.
- Understanding of statistical techniques such as normality analysis, tolerance analysis, and ability to analyze and interpret data with high confidence.
- Must know how to use Minitab or other statistical software.
- Expertise in Sterilization (EO) is preferred (ISO 11135).
- Knowledge in biocompatibility is preferred (ISO 10993 and associated variants).
- Strong analytical, planning and organizational skills.
- Strong interpersonal and communications skills (oral & written).
- Self-starter with ability to work independently under pressure and react quickly to changing priorities.
- Proficient in MS Office Word, Excel, Power Point, Project, Visio.
