This is what you will be doing at Qserve:
As a Regulatory Affairs Consultant at our company you provide specialist consulting services, auditing and/or training in medical device regulations, quality assurance, regulatory compliance, clinical evaluation, and strategic support to medical device manufacturers. With the objective to obtain or maintain or expand market access for our customers to various markets (EU, USA, China) and based on predetermined and agreed deliverables. As a consultant, you may build (technical) documentation and design dossiers in support of CE marking, 510(k), or similar approval processes. Your activities may include strategy planning, reviewing and/or developing technical files, clinical evaluations and quality management systems. You may conduct internal or supplier audits, or deliver interim QA/RA management, or help improve our customers quality processes.
You maintain, develop and share your expertise and knowledge on a specific expert area. On this specific expert area, you will be the point of contact for colleagues and customers. You will pro-actively follow the news and trends in the market to share within our Knowledge Center (blogs, whitepapers, news items, presentations or similar to promote knowledge base and brand of Qserve).