Projectmanager Quality & Corrections
Derks & Derks Detachering
A temporary position as Projectmanager Quality & Corrections for the period of at least 6 months at a global Healthcare company
Offer
- a challenging job at a global Healthcare company
- an operational role in a international environment
- a temporary contract until at least February 2024
Position
As a Projectmanager Quality & Corrections you are responsible for supporting the execution of post-market risk assessment and drive the preparation of Health Hazard Evaluation in cooperation with product technical experts and Medical Affairs. You will work in multifunctional teams contributing with knowledge and experience to ensure proper preparation and execution of Corrections and Removals (C&R), Risk Assessments, etc. often leading a cooperative effort among members of those teams. Besides this you will drive the C&R strategy ensuring reportability decisions per country and execution of activities according to the C&R strategy. Creating all C&R related Customer Notifications and C&R Regulatory Submission reports (e.g. FSCA, 21CFR806) will also be part of your responsibilities. Other tasks may include managing the C&R file documentation and C&R file completion and ensuring that C&R records meet Good Documentation Practices. As Projectmanager Quality & Corrections you will also support the preparation of responses to Regulatory agencies inquiries and provide follow up and continuously track C&R execution and provide ongoing information to IGT Systems C&R management and teams as required. Besides this you will act as a Quality and Regulatory expert for the C&R process.
Profile
- Bachelor in a Technical Discipline preferably in Healthcare, Engineering or Science
- 6+ years of related experience in a medical device or regulated industry preferably in Correction and Removal processes, regulatory submission, Risk Management;
- Project Management skills. 2+ years in project management is an advantage;
- in-depth knowledge of Quality Management Systems and deep understanding of related regulation (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169).
- good analytical skills and process improvement capabilities
- strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers)
- ability to successfully balance and prioritize multiple ongoing projects/tasks
- strong attention to detail and accuracy
- high degree of initiative, engagement, self-motivation and flexibility
Organisation
Our customer is international active in the healthcare industry. They sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With these investments they hope to stay on top of the market. They design the product through the eyes of the end user, combined with an appealing design. The organisation is always looking for improvement of their processes. Therefore, they would like to get in touch with a Projectmanager Quality & Corrections.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/23-285, to Marlies Dingemans: info@derksenderks.nl. For more information, please call, text or WhatsApp Marlies via +31 (0)6 45316342.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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