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.

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