---

---

Location

India | India

---

Job description

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.

---

Job tags

---

---

Salary