LNE/G-MED North America, Inc. is seeking Certification Project Managers to fill in their Headquarters outside Washington, DC, and in their California office. LNE/G-MED is an established, 100-year old company that provides independent certification services, product testing and training for regulatory compliance and quality assurance worldwide.
Due to rapid growth in North America, LNE/G-MED North America seeks energetic, qualified, and competent project managers responsible for medical device manufacturing clients.
Take advantage of the opportunity to work on the frontier of medical device innovation and have a finger on the pulse of the ever-changing international life sciences regulations.
Ensure the performance of the certification activities according to the Quality objectives:
- Follow-up of audits and technical evaluation files throughout the certification cycle
- Coordinate clients’ files, audits, and auditors to ensure the clients’ certification goals are met
- Interacting with clients and team members along the certification process
- Evaluating client files and reviewing of technical topic
Support Business Development with regulatory and technical knowledge, as needed
Manage the clients’ medical device approval procedures while applying own (or someone else’s, as needed) technical and regulatory knowledge
The position can evolve to Technical File Assessor and/or Lead Auditor.
- Minimum 4-year degree in a Life Science (Biology, Chemistry, Physics, etc.) or Engineering (Electrical, Mechanical, Bioengineering, etc.)
- 4 years of experience in the medical devices industry in R&D, design, manufacturing, regulatory, or quality. Preferably in the non-active or active medical devices fields
- Knowledge of and experience working with quality management systems, specifically ISO 13485
- Knowledge of and experience with the European medical device regulatory scheme (MDD, AIMDD, etc.)
- Analytical thinking and problem-solving skills
- Pro-active attitude and excellent organizational skills, with the ability to keep up with several projects
- Ability to travel domestically, with occasional overseas travel
- Clinical or medical experience
- Excellent public speaker
- Lead Auditor (ISO 13495) certification, other notified body Lead Auditor qualifications
- Additional languages: French, Spanish
LNE/G-MED North America is an Equal Employment Opportunity.