Senior Quality Assurance & Regulatory Affairs Manager (m/d/w)

Job description

Senior Quality Assurance & Regulatory Affairs Manager

What does this position offer to you?

● Competitive remuneration package - €70K - €80K

● Work for the top company in their field

● Fast-paced, intellectually intense, service-oriented environment

● Diverse training and possibilities to grow and expand your skills

● Location based in Rosenheim

What will be your tasks?

● Responsible for verifying Design transfer activities to ensure compliance to internal procedure and regulatory needs

● Maintenance and further development of the already existing QM system according to EN ISO 9001, EN ISO 13485 and 21 CFR 820

● Collaboration in the compilation of the technical documentation of Class I products

● Develop quality assurance specifications, test methods, sampling plans and related written procedures

● Responsible for Quality Assurance tasks in supplier management

● Ensure the role of quality/regulatory representative to the authorities and our clients

● Ensure the evaluation of risk analyses

● Tracking conformities and management of corrective and preventive actions

Who you are: You…

● 3+ years of relevant industry experience focused on Medical Device - Quality or Regulatory Affairs field

● Knowledge of Quality System Standards/Regulations (ISO 13485, 21CFR Part 820, MDD93/42/EEC, ISO 14971, WHO GMP

● Knowledge of approval regulations for medical devices

● Support in Validations activities including equipment qualifications, master validation plans

Do you want to know more?

Once you have applied with your CV (no letter of motivation is needed), we will be discussing all your interests and needs in detail. We will also contact the client in your behalf, introduce you to him / her and make sure that you are prepared very well for the upcoming interviews.

If the above-mentioned position doesn't match your needs, then I would suggest to contact me directly for what I have available.

Contact Details:

● E-Mail: p.cioran@sciproglobal.de

● Tel: 089 / 21 09 39 79

● Xing: https://www.xing.com/profile/Patricia_Cioran2/cv?sc_o=mxb_p

● LinkedIn: https://www.linkedin.com/in/patricia-cioran-8a4a0549/