Are you looking for a fast growing international organization, where you play ping-pong in Germany and drink coffee in the Netherlands? Do you have a hands-on mentality but would you also like to push your boundaries by thinking and growing with us and all this with a SMILE?
Then we are looking for you!

We are looking for a proactive:
Regulatory Affairs & Quality Assurance Manager
Heerlen
1,0 FTE

Main purpose of the job?
The RA & QA Manager is a hands-on working manager who is responsible for Regulatory Affairs, Quality Assurance, Quality Control and compliance within international medical (device), biocides and cosmetic regulations. The RA & QA Manager is responsible for products produced by Arion Manufacturing B.V. and Arion Slide Solution. The RA & QA manager is also responsible for the Quality Control department, the QA system and the release of the products that meet the specifications of Arion. The RA & QA Manager is responsible for supporting the management and development of the Quality Management System (QMS) and regulatory obligations of the organization and its products throughout the full product lifecycle. The RA & QA Manager will also be assigned the formal role of PRRC for all medical device products which are produced by the legal manufacturer of Arion Manufacturing B.V. and Arion Slide Solutions B.V.

Key areas of responsibility?
The RA & QA Manager will be responsible for planning, directing or coordinating work in the production process in accordance with regulations and relevant standard operating procedures and work instructions. In addition, the RA & QA Manager is responsible for quality and regulatory compliance of products produced by Arion Manufacturing B.V. and Arion Slide Solutions B.V. through:

• Ensuring the submission and maintenance of product registrations worldwide, oversee the regulation process for products requiring governmental approval and handling all domestic and international government interactions.
• Writing and preparing registration dossiers. Preparing the content of new Market Authorizations and variations (national/DCP/MRP);
• Creating necessary statement letter to support registration of products or tenders;
• Collecting relevant data from various stakeholders and, where necessary, adapting the data obtained and/or requesting additional information / additional agreements so that the requirements of the registration authorities are met;
• Communication with government agencies and authorities; assess consequences, substantive processing of or rebuttals to any concerns;
• Provide support about Regulatory Affairs and Quality Assurance to other departments such as R&D, Quality, Manufacturing and Marketing for products produced by Arion Manufacturing B.V. and provide support to other departments as the Business unit Manager, Product Manager and Marketing department of for products produced by Arion Slide Solutions B.V.;
• Determining the strategy for international registrations and assessing the registration impact;
• Managing and updating the SOP and WI for Arion Manufacturing B.V. and Arion Slide Solutions B.V.;
• Responsible for an up to date raw material & product database;
• Facilitating the R&D team and QC team of Arion Manufacturing and facilitating the Business Unit Manager and Product Manager of Arion Slide Solutions;
• Maintaining RA, QA and QC projects;
• Building a balanced QA/QC team to ensure future continuity of all key capabilities;
• Adequate documentation practice and data integrity;
• Managing internal and external stakeholders and trade association relationships;
• The RA & QA Manager will be assigned the formal role of PRRC (Person responsible for Regulatory Compliance) for Arion Manufacturing B.V. and Slide Solutions B.V.

Other tasks & Activities

• Ensure high level of interaction between R&D, RA & QA, QC and the production of Arion Manufacturing;
• Manage multi-disciplinary project teams and external parties;
• On-the-job training of key stakeholders, internal and external such as the R&D, RA & QA and QC team of Arion Manufacturing and the Business Unit Manager and Product Manager of Arion Slide Solutions;
• Grow the QC & QA team, bringing the team to a higher level;
• Continuously keep one’s professional knowledge up to date.

Required skills and experience

• Master / PhD degree in Pharmacy, Medicine, (Cosmetic) Chemistry or equivalent;
• At least five years relevant international working experience in the medical device, pharmaceutical or cosmetic industry, preferably in the field of RA & QA;
• Excellent team management and project management skills;
• Excellent knowledge of interpreting and applying laws/regulations, preferably related to (raw materials for) medical devices (MDR and relevant FDA articles);
• Fluent in English (oral and written);
• Strong analytical and persuasive skills. You know how to inspire people;
• Accurate, stress resistant;
• Work independently in a result driven culture – a pro-active “can-do” attitude;

We offer

• Working at a nice (informal) international growing company which brings interesting challenges, in an ambitious and professional team where cooperation is key;
• Fixed-term contract with a view to permanent employment;
• 29 vacation days on a full-time basis;
• Travel allowance of €0.23 per kilometer with a maximum of 45 km per day;
• Pension plan with Nationale Nederlanden;
• Collective health insurance through CZ;
• Training and development opportunities.

Also watch our inspiring video:

https://www.youtube.com/watch?v=Fwez_XL-P5U

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