Danaher Regulatory Compliance Specialist Vacancy – Apply Online
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world-class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental, and applied solutions.
Job Title: Sr. Quality Systems and Regulatory Compliance Specialist
Location Gurugram, Haryana, India
Category Quality & Regulatory Affairs
Job Id R1171726
Education and Experience:
- Master’s degree in science ( Pharmacy), medical or technical field\
- 4-8 years of experience in the medical devices industry (IVD can be a plus)
Knowledge and skills:
- Excellent verbal and written communication skills
- Knowledge of International Organization for Standardization ISO13485
- Knowledge of International regulations QSR for the USA, CE Directive, and Regulation for India.
- Excellent planning and organizing skill
- Exceptionally strong team player with excellent interpersonal and communication skills
- Able to confidently deal with ambiguous issues and provide input towards suitable actions.
Preferred Qualifications:
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret the quality problems and establish practical solutions within a dynamic business environment.
- Experience in leading continuous improvement efforts, in both quality systems and products.
- Knowledge of the process of establishing facility QMS certifications.
- Cross-functional experience with products and commercial operations processes to influence change at all levels within the organizationVisio and Project knowledge desirable.
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