We are the new kid on the block. With tons of experience and perspective
Anteris has been founded in 2014 and supports medical device product development and compliance projects in the medical device and pharma/biotech industries. In particular, we help new entrants into the exploding Biosimilars market to enable the success of their products with compliant development of the right medical devices or medical device components in a combination product, both in the US and the EU.
We focus our efforts to support clients who either lack resources familiar with medical device regulations and processes, or wish to complement their existing resources. This is being done either on client’s premises or in-house in the anteris offices near Munich.
- Preparation of development, quality and regulatory documents in compliance with regulatory standards, e.g. MDD, CFR 820.
- Duration: 6-8 months, potentially longer. (The project will be limited to 6-8 months, but can be extended depending on the customers resource situation.)
- Start: As soon as possible
- Location: Munich area
- Minimum 3-4 years of experience in medical device documentation
- Fluent English (all documents and all project communication is in English)
- Driver's license
- EU citizen
- Within ongoing development and lifecycle management projects support is needed for the establishment and update of DHF and DMR documentation including: requirements engineering, change management, design verification / re-verification, design validation, process validation, transport validation, design transfer, etc.
- You will be working in an existing project as a team member reporting to the responsible project leader within an established ISO 13485 quality system.
- The work shall be done on customer site (1h drive from Munich), in the anteris office in Holzkirchen and in home office (depending on the project situation).
If you are interested, please contact us at email@example.com.
Then we are looking forward to receiving your application!
Notice to recruiters
Please be aware that anteris medical will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to anteris medical or directly to anteris medical employees will be considered anteris medical property. anteris medical will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. anteris medical will consider any candidate for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees.