Quality Assurance & Regulatory Affairs Manager

Location: Bengaluru

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 Pub Med,
Clinical Trials.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