- Location
- Raynham
- Type
- Full-time
- Department
- Legal
- Experience
- 3+ years
- Education
- PhD
Description
Raynham, MA
Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to
- European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
- US FDA 510(k) submissions or Notes to file, as applicable
EDUCATIONAL REQUIREMENTS
Bachelor's (minimum 3 years’ experience) or Master’s (minimum 2 year of experience)
Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of
experience) is preferred.
PROFESSIONAL EXPERIENCE REQUIREMENTS
- 3 to 5 years of experience in Medical Device industry especially within regulatory, quality or alternatively within engineering
- Proven exceptional written and oral communication skills
- Strong knowledge of
- ISO 13485 and ISO 9001, QSR
- Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
- MEDDEV guidance documents applicable to Medical Devices products and processes
- FDA requirements
Skills
FDACompliance