sr. quality systems and regulatory compliance specialist in gurgaon

posted
contact
randstad india
position type
permanent
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posted
location
gurgaon, haryana
function
Pharma, healthcare & lifesciences
position type
permanent
experience
4
reference number
61768
contact
randstad india

job description

sr. quality systems and regulatory compliance specialist in gurgaon

JOB DESCRIPTION
POSITION SUMMARY:
Responsible for general support and maintenance of the Quality System/Regulatory Compliance within
the requirements of the international and national standards such as the QSR, ISO 13485, 98/79/CE
Directive for IVD including;
the document control system, corrective and preventive action system, internal audits and
administrative support
Material quality assurance, batch record issuance, management of the quality documentation.
Field Safety Corrective Action and Reporting the Adverse Events Report to the competent authorities.
Ensure compliance as per MDR 2017, European regulations, ISO 9001, ISO 13485. MINIMUM REQUIREMENTS:
Education and Experience:
Master’s degree in science (Biochemistry, Biotechnology, 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 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 REQUIREMENTS:
Experience working with medical device quality systems in compliance with MDR and ISO 13485
Able to interpret quality problem 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.

skills

QMS, Regulatory affairs, compliance

qualification

Any