Job Description

Do you want a job with a purpose?

And do you want to make healthcare safer, better and more reliable?

Join our Team!

Roles and Responsibilities

• You will ensure ongoing Quality and Regulatory compliance of products and services
• You drive and manage the implementation of the DH Healthcare GmbH Quality Management System to the Site in India.
• You ensure the effectiveness of Quality Management System in the Indian Organization.
• Reporting to the Pre-market QARA Manager, the Pre-market QARA Specialist will ensure, in partnership with business partners, the safety, efficacy and quality of products, medical devices and services offered by DH Healthcare. This is carried out via the sound application of risk management principles and through full compliance with all applicable quality, regulatory and legislative requirements
• You will provide guidance and define regulatory plans and strategies, working with the project core team. You will also be accountable for the implementation of the pre-market regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances
• You drive and monitor timely resolution of NC and CAPA records, identifies area for improvement, takes part in the preparation and progress of internal and external audits and supports quality management review, quality training and the document and records management process to maintain and improve compliance.

• Minimum 3-5 years of experience in a regulated industry \xe2\x80\x93 preferably medical device, pharmaceutical or related \xe2\x80\x93 holding a position in project management, quality management, or quality assurance and regulatory affairs position.
• Ability to analyze, understand, and interpret regulations and standards for a more general business audience
• Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR
• Knowledge of and experience in:

• Quality Management Systems, Internal and External Audits
• Design control regulations and requirements
• Medical device classification rules and regulations
• Medical device regulatory submission regulations and requirements
• Risk management regulations and requirements
• Software development methodologies and practices
• CAPA/NCR regulations and requirements
• Usability, safety and product related standards
• Awareness of Medical Device product safety and Security Standards including ISO 27001 GDPR (Preferable)
• Awareness of other international system and product regulation in Medical Device Industry
• Strong problem solving and project management skills;
• Excellent communication (verbal and written), research, organizational and interpersonal skills
• Ability to work independently towards deadlines and strong attention to detail
• Expert PC operation skills, including knowledge of enterprise-wide software applications
• Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
• QMS tools (CAPA, regulatory clearances, KPIs) (Preferable)

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