Director Vigilance
Komorniki/Plewiska, PL
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Key Responsibilities:
- Develop and execute strategies for the complaint handling and vigilance function in line with global standards.
- Oversee departmental operations, ensuring efficiency, quality, and cost-effectiveness.
- Lead investigations, reportability assessments, and regulatory submissions for adverse events.
- Drive continuous improvement projects to enhance processes and ensure compliance.
- Collaborate with internal and external stakeholders to foster a culture of quality and compliance.
- Stay abreast of evolving regulatory requirements and implement necessary updates.
- Act as a key liaison with regulatory authorities for escalated matters and audits.
Qualifications:
- Bachelor's degree in Business, Science, or Engineering (Master's degree preferred).
- At least 7 years of experience in the Medical Device or Pharmaceutical industry.
- At least 7 years of experience in Managerial role
- Knowledge of ISO 13485 and FDA Quality System Regulation.
- Proven leadership, interpersonal, and stakeholder management skills.
- Expertise in change management, analytical problem-solving, and continuous improvement methodologies (Preferred 6 sigma, DMAIC)
- Strong communication skills and proficiency in MS Office.
- Fluency in spoken and written English.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- The chance to lead impactful initiatives in a global organization.
- Competitive compensation and benefits package.
- Company car
- Hybrid work (weekly 2-3 days at the office)
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About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.