Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako’s know-how, reagents, instruments and software to make precise diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1000 people and being present in more than 80 countries, Dako covers essentially all of the anatomic pathology markets globally.
The Director of Regulatory Affairs/Quality Assurance Dako NA is a member of the global QA/RA Leadership team, reporting to the corporate vice president of QA/RA. In this role, the person is responsible for the QA/RA compliance programs and systems as applicable for Dako NA.
More specifically, the overall tasks are to:
Provide Leadership in implementing and further developing quality and regulatory strategies, in alignment with the overall business goals
Provide Leadership to teams, peers and the site organization, ensuring the quality system is in compliance with relevant regulations, and necessary governmental approvals being maintained
Lead the QA/RA site department, providing the right capacity and competencies matching the QA/RA needs to
support the business functions, cross-functional projects and initiatives
Interact with regulatory bodies to fulfill reporting requirements and obtain new product clearances
Build key regulatory business relationships in Pharma partner collaborations
Responsible for developing business wide regulatory strategies for marketed products as well as the product pipeline
Responsible for delivering high quality and on time regulatory submissions and filings to the FDA and other competent authorities
Responsible for Field Corrective Actions, Recalls and Advisory Notices
Responsible for the maintenance and continuous improvement of the global QMS within areas of responsibility
Responsible for product quality management, including customer complaints handling, CAPAs and related to correct and improve quality of material, products and processes
Responsible for QA/RA responsibilities adhering to the entire product life cycle management process
Responsible for providing QA/RA resources ensuring quality and regulatory standards are fulfilled through new product development
Responsible for the support to the operations function, assuring the right checks and controls are in place to ensure product quality and quality compliance
Management Representative responsibility for Dako N.A
Bachelor’s degree in Engineering or Life Sciences discipline
In-depth management experience in QA/RA in a leading role, preferably in an international environment
Well experienced in FDA new product clearances with proven success
Experience from the medical device and/or drug industries
Strong knowledge of quality management systems, including but not limited to ISO quality standards, QSR, etc.
Visionary thinking with a desire to excel, inspiring others
Confident and out-going personality
Excellent influencing skills
Good business acumen
Pragmatic and business oriented
Able to identify and focus on the key priorities
Self-starting, self-reliant, courage of conviction
Passionate, enthusiastic and able to inspire others to drive results
Structured and well organized
Willingness to travel globally on a regular basis
Dako offers a dynamic and international position in a companythat is expanding into new markets and scientific disciplines. The job is independent and demanding, however also among colleagues with high competence, commitment and a good sense of humor. The organization is informal and with a high degree of trust to employees. We offer an attractive salary package, pension and health insurance.
For further information, please contact TBD. Please forward your application and CV to TBD as soon as possible.
All applications will be handled confidentially
Dako - 2 years ago
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Dako (www.dako.com) is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's know-how,...