QA/RA Manager, Cook Biotech Europe
We are looking for a dynamic, team player who can ensure that Cook Biotech Europe (CBE) is in regulatory compliance as a European Authorized Representative for our USA-manufactured biomaterials for tissue regeneration. This person will be responsible for establishing the CBE Quality Management System (QMS) and performing audits of CBE’s distributors in Europe to ensure compliance. The person in this position will be part of CBE’s management team.
The QA/RA Manager and PRRC will report to the Director, European Business, Cook Biotech. The position is based in our facility in Bjaeverskov, Denmark. Some travel, primarily within Europe, is to be expected.
We are a small team in Europe taking care of Cook Biotech’s business in Europe. Our organization has the feel of a start-up company with a unique, scientifically documented product and the support of Cook Group, a large global company.
- Will be overall responsible for quality and regulatory tasks
- Ensure that conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
- Ensure the reporting obligations referred to in Articles 87 to 91 of the EU MDR are fulfilled
- Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date
- Ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) of the EU MDR
- In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU MDR is issued
- Perform audits of CBE’s distributors to ensure compliance
- Remain current and apply understanding of relevant controlling regulations cited in the Quality System Manual in carrying out job responsibilities
- Assist in the coordination and compliance with requests of regulatory authorities during inspections and during inspections of contract service providers
- Ensure that developed procedures and specifications are appropriate and followed, including those used by suppliers (distributors etc.)
- Assist in complaint investigation
- Train new personnel in both general and specific QA processes
- Maintain company quality and safety standards
Cook Biotech operates in a global environment that requires excellent organizational and communication skills. The person in this position will have the ability to execute activities aligned with a clear, strategic direction and a flair for collaborating at all levels. This position requires an eye for detail and at the same time the ability to juggle multiple projects across the organization. Must be able to work independently within areas of responsibility, and also thrive on teamwork in an international and dynamic, cross-functional organization. Must be a team player with a positive and committed approach to tasks, along with a proactive attitude toward change and new opportunities.
CBE’s QA/RA Manager PRRC will be expected to have the following qualifications:
- Master’s degree in law, medicine, pharmacy, microbiology, biomechanics, engineering or another relevant scientific discipline
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
- Experience working in a regulated industry, such as pharma or medical devices
- Familiarity with EU rules and regulations for medicinal products preferred
- Experience with human/animal tissue products for medical applications
- Advanced organizational and mathematical skills, including calculations and statistics
- Must work and interact effectively and professionally with others
- Must have effective oral and written English communication skills and excellent problem-solving skills
- Ongoing commitment to upgrading knowledge, job skills, and abilities in addition to competency related to all duties
- Resident in or willingness to relocate to Denmark
Cook Biotech’s company culture is based on a set of strong common values where responsible, competent, and professional employees are our most important resource.
We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty, and humor are highly appreciated.
The staff of Cook Biotech helps uphold the company’s philosophy of being a visionary leader and partner in discovering, developing, and delivering transformative medical solutions for improving life.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance,¬ and free use of the company’s gym.
For further information about the job, please contact Director, European Business, Cook Biotech, Jesper Thyregod, by phone: +45 23 21 10 44 or by e-mail: email@example.com.
Deadline for applications is August 5th, 2019
Cook Biotech Inc. is dedicated to providing advanced tissue-repair products for improving patient outcomes globally. Our products are manufactured using proprietary extracellular matrix (ECM) technologies and manufacturing processes. They are derived from porcine small intestinal submucosa (SIS) and other ECM-based biomaterials.
We collaborate with partners and distributors to make our products available under several brand names, including: AxoGuard®, Biodesign®, DynaMatrix®, FISH™, HaloShield™, OASIS®, and tarSys™. Cook Biotech is part of Cook Group and is affiliated with Cook Medical in Bloomington, Indiana, and Cook Medical in Bjaeverskov, Denmark.
For more information about Cook Biotech’s products, visit cookbiotech.eu.
For more information about Cook Group, visit cookgroup.com.