Quality Assurance Analyst

Job Description:

Job Location: Gurgaon 

Job Title: Post Market Surveillance Associate 

Essential Duties and Responsibilities.

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 regulatory 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 structure 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 a 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. 

 • 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 the Healthcare industry) - Preferred but not mandatory.