Post Market Surveillance Specialist
Zimmerbiomet
- Bangalore, Karnataka
- Permanent
- Full-time
What You Can ExpectPosition is responsible for post market surveillance (PMS) assignments, including document ownership of initial PMS plans, revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS review according to the PMS schedule.Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)How You'll Create Impact
- Document owner for Post Market Surveillance Activities; Initial PMS Plans (PMSP) and Review (PMSR) records; responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable).
- Ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies.
- Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders and elevating at-risk findings to senior management.
- Track execution of PMS plan according to requirements; report to management on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines met.
- Completes routine audits of PMCF commitments against PMSP to ensure quality and transparency of commitments is maintained.
- Strong communication skills, both written and verbal; experienced intrapersonal skills and the ability to influence cross functional stakeholders and work in a fast-paced environment prone to change. Strong attention to detail and ability to manage multiple projects and meet deadlines.
- Thorough knowledge of Global Medical Device regulations relative to Post Market Surveillance (Medical Device Directive & Revisions, ISO 14155, FDA Section 515 & 522, FDA MDR requirements, etc.) is preferred.
- Proficiency with Microsoft Office suite, and advanced spreadsheet or Microsoft Excel experience preferred.
- Demonstrated senior Level capability through autonomous working, strong critical thinking, end?to?end project ownership, and the ability to execute responsibilities independently with minimal supervision.
- Thorough knowledge of global medical device regulations related to post-market surveillance (Medical Device Directive and revisions, ISO 14155, FDA Sections 515 and 522, FDA MDR requirements, etc.) is preferred.
- Seniority will be determined by level of autonomy, critical thinking ability, project ownership, and the capacity to work independently.
- Excellent English verbal and written communication skills.
- Direct experience with PSURs and PMS plans is preferred; however, candidates from adjacent areas such as product surveillance or complaints handling will also be considered, as this role may represent a natural step up.
- Prior experience with clinical trials is considered an asset.
- For junior positions, motivated candidates with backgrounds in quality or product surveillance will be considered, with priority given to those who have demonstrated proactive PMS experience.
- Strong project management and organizational skills.
- Proven ability to manage multiple projects concurrently while meeting strict deadlines.
- Experience Range: 2+ Years.
- Bachelor's degree in health, life sciences, engineering or a similar discipline required.
- Less than 20%
- EOE/M/F/Vet/Disability