Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. Beckman Coulter is an operating company of Danaher Corporation.
Croatian subsidiary, Beckman Coulter d.o.o., is reputable diagnostic supplier in Croatia, but also taking care in terms of business and giving support to local organizations in surrounding countries. Having full range of diagnostic products in market, we are further expanding in both hospital and private lab areas.
We are looking for person to work on the position:
Quality Assurance Regulatory Affairs Specialist (m/f)
(fixed term contract)
Place of work: Zagreb
The position owner will coordinate post market regulatory activities on regional level. In addition, the role involves supporting pre and post market regulatory activities associated with external agencies and internal departments for In Vitro Diagnostics products, ensuring all documentation complies with Beckman Coulter policies and procedures and applicable Regulatory requirements. The role also involves supporting the Quality Management System and all its elements to maintain compliance to ISO 9001 for our local entities.
You will promote the compliance to our processes internally and will be involved in CISEE-wide QRA initiatives and have a positive approach to change.
Key tasks and responsibilities:
- Sustain and continually improve the quality processes needed to support the Commercial Quality organization and the ISO 9001 Certification
- Support and participate in inspections/ internal audits
- Coordinate post market regulatory activities on regional level and complete reporting activity to Competent Authorities
- Support regular local QSMR meetings
- Communication to management on Quality and Regulatory affairs issues, which require addressing
- Identify critical product/process issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities
- Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements
- Review regulatory and compliance publications to disseminate relevant regulations, guidelines & policies to all functional departments
- According to business needs proceed with on time pre-market /notification process completion
- Implementing Visual Management activities including updating Daily Management boards and Monthly Performance Bowlers
- Develop, improve and implement local regulatory procedures and work instructions for regulatory processes
- Support Supplier Control activities
Required qualifications, skills and traits for success in the job:
- Bachelor or University Degree
- Internal or Lead Auditor qualification and Knowledge of quality assurance systems issue based on EN ISO9001 or ISO13485 standard is an advantage
- Knowledge on MD and IVD regulations is an advantage
- Knowledge of work with PC (Word, Excel) necessary, independence, flexibility and organizational skills
- Quality/Regulatory Affairs experience of at least 1 year
- A systematic work approach and an ability to manage several projects simultaneously
- Ability to manage changes effectively in order to better serve our internal customers, external customers and legislative demands
- Experience participating on a cross functional team is an advantage
- Excellent written communication skills are essential (verbal/written/presentation/relationship building) with ability to work collaboratively with internal customers, cross-functional project teams and regulators
- Fluent in English – written and verbal
- Fluent in Croatian – written and verbal
- Travel ability on domestic and international scope up to 10%
Position is opened as a replacement for maternity leave and contract with candidate will be signed for limited period of time.
Only short-listed candidates will be contacted.
All applications will be treated in the strictest confidentiality.
The professionals interested in this position should send a comprehensive CV via application link. Closing date for applications is 29th of July 2020.