QA RA Manager

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.

Develops, registers and markets innovative consumer healthcareproducts.

ROLE DESCRIPTION

Entrepreneurial company with a proven track record in the development and sales of innovative and effective self care medication (OTC) products. Our expertise lies in the field of product development and sales through our international distributor’s network in over 25 countries. Located in the city centre of Amsterdam and not easy to reach by car.

RESPONSIBILITIES

- Responsible for Regulatory affairs, i.e. preparation, registration and maintenance of CE Technical Files (TF), Device Master Records (DMR) and CE Design History Files (DHF) for conformity assessment for medical devices (MDD 93/42/EEC, ISO 13 485, FDA);
- Responsible for Access to Markets Worldwide (regulatory) and maintaining marketing authorizations;
- Leading all regulatory activities for assigned project(s) and territories in line with(ISO) requirements, regional requirements, company policies and procedures.
- Responsible for Quality Assurance, i.e. acting asManagement Representative in the QMS; monitoring the compliance of company quality policy, procedures, forms and registrations (ISO-­‐13485, GMP) and responsible for internal and external audits.
- Maintain Quality Management System (QMS) and perform relatedactivities (Complaints handling, post market surveillance, CAPA)
- Member of Design & Development team
- Works proactively to buildand maintain network with Notified Bodies and country competent authorities (MoH’s);
- Responsible for solving all quality related issues
- Assure that the company and suppliers work according to regulatory requirementsin close cooperation with the Supply chain manager
- Carry out internal and external audits at (potential) suppliers
- Manage audits of Notified bodies and clients in close cooperation with QA/RA advisers
- Monitoring/reporting quality related issues at company’s distributors

REQUIREMENTS

We are seeking people with a high level of education (bachelors or masters title) and pragmatic personalities, an international orientation, and a genuine appreciation of consumer health products and medical devices. Profile we look for:

- A minimum of 8 years of experience, with most of this experience in the consumer health or medical device sector.
- Proven experience in RA (medical device) and ISO quality management systems (ISO 13 485)
- Must be capable of developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities
- Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
- Background in consumer health products, pharmacy or related medical field
- You are punctual and solution driven. You react decisive on actual market developments
- Experience or affinity working within smaller enterprises
- Fluent written and spoken Dutch and English. German, French and/or Spanish is advantage

OTHER

Being part of a culture where ideas are valued and initiative encouraged.If you have what it takes to give our customers more freedom, more choice and the chance to try new things, you can expect the same from us in return. An ambitious and dynamic company and is offering a challenging role, with lots of opportunities and competitive terms of employment in the field of consumer health products.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.