We are looking for a Regulatory and Quality Assurance Specialist (MD products) for the quality organisation in Assens, Denmark
The future is being created today. At Kiilto, we invest in the future every day by promoting occupational wellbeing, encouraging innovation and making our operations more and more sustainable. We are guided by the desire to be an environmental leader, using our expertise to create success stories for our customers. We are local, innovative and insightful. Would you like to add your own chapter to our hundred-year story of growth?
We are looking for a
Regulatory and Quality Assurance Specialist, MD products
In this role, you will be responsible for the RA/QA aspects of the Plum emergency eye wash and plaster systems for personal use, and for maintenance of the ISO 13485 quality system in Assens. You will perform internal and supplier audits regarding Plum medical devices, and assist during Notified Body audits and inspections by the competent authorities. Your tasks will also include collecting and coordinating information for submission to regulatory agencies, and maintaining experience of national and regional requirements for the regions in which Plum medical devices are registered. In addition, you will review labels and marketing materials for regulatory compliance, and sign quality agreements. You will work closely with our production operation and be responsible for deviation handling. You will also bring your expertise and other contributions to product portfolio development.
The Danish company Plum A/S, which was established in 1860, has been a member of the Finnish group Kiilto since 2019. You will be located in Assens and work with the local safety team, but will be part of and report to Kiilto’s group-level quality organisation, which is located in Finland. This position will require occasional travel to other Nordic countries in addition to Finland.
Skills and experience
- Minimum of a B.Sc. in e.g. biology, chemistry or pharmacy
- Experience within the medical device industry and of working with ISO 13485 and MDD/MDR
- Knowledge of FDA regulatory requirements for medical devices/OTC drugs would be a plus
- Experience of regulation in Russia, China and South East Asian countries would be an advantage
- Fluency in spoken and written English
- Structured way of working and ability to manage projects with deadlines
- Teamworking spirit
We will provide in-depth orientation in new tasks, as well as strong support and the opportunity to work with a thriving international company providing top-quality products and services.
For more information, please contact our RDI Director Oili Kallatsa, +358 505769 243, between 8am and 10am (CET) on 13 August or between 1pm and 3pm (CET) on 20 August, or Executive Vice President (Workplace Safety Division) Bo Winther Barkholt, +45 3066 7261, between 2pm and 4pm (CET) on 13 August and 15 August.
Please submit your application with a salary request and CV no later than 25 August 2019 on our website.
We operate in compliance with Kiilto's recruitment process and will treat all contacts concerning the post with absolute confidentiality. We will send video interview questions to some of the applicants. We also ask applicants to reserve 17 September for a possible job interview.
Kiilto is a growing family-owned company from Finland, with a hundred-year history and a vision looking ahead to 2080. We develop, manufacture and market chemical industry solutions in four business areas: professional construction, industrial bonding and hygiene solutions, professional cleanliness and hygiene, and consumer business. The key principles underlying our operations are environmental leadership, localism, and commitment to the future. We operate in 12 countries and employ around 1,000 people, whose wellbeing and expertise are critical to our work on behalf of our customers. See our websites for more information about Kiilto and Plum.