Quality Assurance Analyst Junior 3+yrs Job in Rangam Infotech Pvt. Ltd.

Description:
Job Location : Gurgaon
Job Title :
Post Market Surveillance Associate
Summary :
This position is intended to support Post-Market Surveillance (PMS) activities, acting on behalf of the EMEA PMS Team. Under the responsibility of the EMEA PMS Manager, you directly oversee the activities associated with the performance and safety of the products on the market (passive feedback such as complaint and active feedback collected through diverse initiatives).
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulations including:
o Gap assessment of current processes and regulation requirements;
o Implementation of new requirements that align and support peripheral teams and processes;
o Implementation and maintenance of the Periodic Safety Update Report (PSUR);
o Implementation and maintenance of the Post Market Surveillance Plan;
o Implementation and maintenance of the Post Market Surveillance Report;
o Collaboration with cross-functional teams to support EU MDR requirements, escalations, and updates.
Analyze complaint and product failure data;
Prepare and submit regulatory reports to Competent Authorities;
Participate and/or Lead Active Market Surveillance activities (i.e. surveys, etc.).
Provide feedback and escalate any concerns or issues within the process.
Support execution and improvements to the current PMS processes.
Pro-actively recognizes and identifies current and future problems, structures them and quickly translates them into solutions and opportunities.
Execute on projects as required by Manager.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
Demonstrate strong written and verbal communication skills and critical thinking;
Exhibit strong leadership skills and emotional intelligence;
Strong computer skills (Excel, Word, PowerPoint, database);
Attention to detail;
Ability to lead meetings or cross functional teams to come to resolution when facing ambiguous situations;
Ability to influence without authority;
Demonstrate cross functional communication skills in email and in person;
Excellent organizational and analytical skills;
Ability to handle and manage workload independently;
Prioritize numerous activities in a rapid paced environment;
Contribute to team-oriented tasks;
Fluent in English (read & write).
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Degree in Healthcare, Quality Management, Engineering, Life Science, or equivalent (S.T.E.M.) Preferred but not mandatory;
Experience within an international company operating in a highly regulated environment (preferably within Healthcare industry) - Preferred but not mandatory.