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

Lawrence Harvey

Job ID :


Company Type :

Staffing Firms

Industry :

Manufacturing and Production

Education Level :


Address 1 :

Western Europe,Germany,Rosenheim (83024),

Key Skills :

Quality Assurance , Regualtory Affairs , Medical Devices

Salary :

€70000 - €80000 per annum

Date Posted :

22 Oct, 2019

Company Name :

Lawrence Harvey

Location1 :

Rosenheim (83024)

Job Category :

Quality Assurance Jobs

Experience :


Job Type:


Travel Amount:



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:

● Tel: 089 / 21 09 39 79

● Xing:

● LinkedIn:

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



Phone No. :

0203 327 3072

Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

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