Correction and Removal (C&R) Specialist
Start Date: ASAP
Duration:1 year
Location: Eindhoven
As a Correction and Removal (C&R) Specialist, with one of our promising client within healthcare domain, you will get an opportunity to collaborate with cross-functional teams to ensure the safety and quality of medical devices, directly contributing to global patient care and customer satisfaction.
Functie-eisen
This role en-roles the following responsibilities:
- Driving the Correction & Removal (C&R) strategy and ensuring compliance with global regulatory standards.
- Preparing documents to support critical C&R decisions, including Health Hazard Evaluations.
- Creating and managing all C&R-related customer notifications and regulatory submissions (e.g., FSCA, 21CFR806).
- Managing C&R documentation to meet Good Documentation Practices.
- Supporting responses to inquiries from regulatory agencies.
- Continuously tracking C&R progress and sharing updates with stakeholders.
- Engaging with C&R teams to improve processes continuously.
Competenties
To succeed in this role, you bring along with you the following:
- Bachelor’s degree in a Technical Discipline (Healthcare, Engineering, or Science preferred).
- 6+ years of experience in medical device or regulated industries, specifically in Correction and Removal processes.
- Familiarity with risk management and quality systems (e.g., 21 CFR Parts 803, 806, 820, EU MDR, ISO 13485, ISO 14971).
- Proven project management skills (2+ years preferred).
- Excellent analytical and communication skills, with fluency in English.
Arbeidsvoorwaarden
Primary employment conditions
· A good salary as per industry standards(classification depending on education and work experience);
· 13th month salary (is paid out periodically pro rata)
· 8.33% holiday pay calculated over 12 monthly salaries.
Contract form
· A one-year contract.
Secondary employment conditions
· Pension Plus scheme (build-up from day 1);
· Net €750 to set up your home workplace;
· 25 days of vacation per year based on 40 hours;
· Travel expenses reimbursement;
· Options for working from home with a home work allowance;
· Yacht Academy with a training budget of up to €3,500 per year;
· Referral bonuses up to €1,500;
· Fixed HR contact person (personal guidance at least once a month);
· A professional buddy who is always within reach;
· Knowledge & networking events
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.