Quality Assurance & Regulatory Affairs Manager

Qualification:

Bachelors or Masters in Biomedical Engineering and at least 2 years of experience in quality management system for medical device (ISO 13485).

Experience and skills

 A candidate should have hands on experience on implementing quality management system ISO 13485.

 Candidates must provide details of QMS projects handled.

 Knowledge of ISO and IEC standards such as ISO 13485, IEC 60601 standards

 Qualified internal auditor for ISO 13485

 Knowledge of Indian Medical device rule,2017.

 Fundamental understanding of product development process (for new product development) which includes knowledge of hardware, software, mechanical and regulatory development activities amongst others

Roles and responsibilities

 Manage quality assurance procedure and records.

 Plan and guide various labs test for innovative medical device.

 Prepare and submit device dossiers to regulatory bodies as per client needs.

 Plan and conduct internal audits. Participate in the corrective and preventive action process.

 Imparting QMS training to new joinee.

 Identifying regulatory design input for design team.

 Identifying device related risk as per applicable regulatory requirements.

 Ensuring medical standard compliance - Studying the applicable product standards for medical devices, analysis of all applicable sections,

documenting the requirements and design aspects based on the study. Helping and tracking the implementation.

 Ensure design and test methodologies meets internal and external regulatory requirements

 Excellent understanding of product risk analysis and FMEA processes w.r.t corresponding medical standards (IEC 60601-1,IEC 60601-1-2, ISO 14971 etc).

 Detailed analysis of Software related risks and processes according to IEC 62304

 Detailed analysis of usability aspects of medical devices according to HFE 75, IEC 62366, IEC 60601-1-6, data security standards etc.

 Plan clinical trials for innovative medical device and corresponding regulatory submission related processes and documentation

 Working with cross functional teams to ensure compliance to medical standards and applicable regulatory rules to ensure good quality project

deliverables.

 Conducting clinical literature search using databases such as PubMed, ClinicalTrials.gov and other internet sources to obtain relevant research papers for the given medical device.

 Staying updated on recent trends, developments and advances in medical device standards.

Requirements

Add on skills

 Knowhow of FDA, CE and corresponding compliance requirements

 Experience in IVD device, combinational medical device

 Understanding the requirements the quality system requirements of

Regulation MDR 2017/745 and IVDR 2017/746

Other skills

 Strong analytical skills

 Detail oriented approach to problems

 Strong reviewing skills

 Good communication and presentation skills

 Focus on achieving goals and delivering results

 Collaborate and create alignment in a team environment