I'm partnering with a large Medical Device organization on a 100% REMOTE Regulatory Affairs contract position. The successful individual MUST HAVE:
- Class III Medical Device experience
- PMA or PMA Supplements experience
- Excellent communication & presentation skills
- Knowledge of Chinese Medical Device Regulations (ideal)
- Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agencies. Assist in the registration of products and product transfers
- Oversees the preparation and maintenance of regulatory submissions and files US and EU including US PMA submissions.
- Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
- Provides leadership, personnel development, training, coaching, and mentoring for staff especially regarding US and EU regulations.
- Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
This is a full time, 40 hour per week contract for a minimum of 1 year but extremely likely to extend of become permanent as the project is 3-4 years long.
There will be business travel to China once or twice a year maximum. It will pay between $60-$80 an hour depending on experience.
Sthree US is acting as an Employment Business in relation to this vacancy.