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.

Freelancer - opportunity near Munich - medical devices - technical documentation - compliant to MDD / CFR 820 (m/f)

Job profile

  • 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

Your profile

  • 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

Job description

  • 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 jobs@anteris-medical.com.

Permanent position - Senior Device Development Manager (m/f)

Key responsibilities

  • Preparation of development, quality and regulatory documents in compliance with regulatory standards
  • Developing/compiling Technical Files and Design Dossiers
  • Management of device development projects
  • Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance
  • Driving risk management activities during development and post-launch
  • Performing design validation activities, e.g. planning, execution and reporting of Human Factors studies
  • Consulting with customers regarding quality management and quality control challenges
  • Auditing according to EN ISO 13485 and CFR 820

Your profile

  • Bachelor / Master in engineering or life sciences or with an equivalent combination of qualification and experience
  • Knowledge of regulatory guidelines: Medical Device Directive (MDD) – Directive 93/42/EEC, CFR 820, EN ISO 13485 and EN ISO 14971,
  • Ideally with experience in the field of medical devices of at least 3 years (Master) or 5 years (Bachelor)
  • Client-focused approach to work
  • Excellent communication skills (verbally and in writing)
  • Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and training needs
  • Analytic and business-oriented thinking
  • Ability to travel locally and internationally, as required
  • Ability to work at the client’s site, as required
  • Excellent command of English and German

Benefits

  • Working for and being part of a fast-growing organization
  • Work with a high degree of responsibility and independence
  • Flexibility in terms of working hours and work place
  • The time spent in our offices will be in a suburban setting close to lakes and mountains, yet a stone-throw away from Munich (connected by public transportation and highway)
  • Work on attractive and varying projects in different geographies for different clients
  • Be part of an emerging organization in the explosive growth of the Biosimilar market
  • Attractive, performance-based compensation package

Interested?

Then we are looking forward to receiving your application!

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