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Job Requirements of Post Market Surveillance Consultant:
-
Employment Type:
Contractor
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Location:
Pittsburgh, PA (Onsite)
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Post Market Surveillance Consultant
Careers Integrated Resources Inc
Pittsburgh, PA (Onsite)
Contractor
Job Title: Post Market Surveillance Consultant
Location: Pittsburg, PA
Duration: 12 Months (Possible Extension)
Pay Range: $50/Hr. on W2
Job Description:
Location: Pittsburg, PA
Duration: 12 Months (Possible Extension)
Pay Range: $50/Hr. on W2
Job Description:
- Strategic Ensures that processes for specifying and executing corrections and removal are adequate, ensures alignment with other processes (risk management, CAPA), and ensure the expectations of key stakeholders are met.
- Ensures adequate C&R oversight across Top Management. Ensures tools are available for efficient and effective C&R programs.
- Supports the development of process for specifying and executing C&R are adequate to ensure the expectations of local key stakeholders are met.
- Facilitates C&Rs by ensuring the coordination and or creation of C&R file documentation, C&R file completion and C&R responses.
- Prepares key documents such as Health Hazard Evaluation documents, product C&R files and various internal reports.
- Ensures alignment between risk assessment and management documentation and C&R files.
- Monitor and report on metrics on the C&R KPI's and generation of periodic reports.
- Monitors and coordinates the different sub-system feeders to this process and ensures CRRB (Correction & Removal Review Board) input and decisions are timely.
- Prepares and manages key documents such as Health Hazard Evaluations, Correction and Removal documents, UAL/CAL, Regulatory Reports, Periodic Update Reports, Termination Requests, and various internal reports.
- Continuously track field actions and provide ongoing information on progress key business partners and to FCO team, Regulatory Operations teams as required.
- Provide actionable and insightful C&R analytics across the organization and Management
- Submits FSN Communication to the Competent Authorities and or other regulatory agency as required by Country/Market
- Monitors KPI and escalate when needed to ensure timely closure.
- May support the resolution of FCO prioritization in local Markets in alignment with C&R priorities across Client.
- A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in a creative way.
- Has complete knowledge of company products and services.
- Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team.
- Works on issues of diverse Product where analysis of situation or data requires review of relevant factors, including an understanding of current business trends.
- Follows process and operational policies in selecting methods and techniques for obtaining solutions.
- Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
- Develop and administer schedules, performance requirements.
- Has budget responsibilities
- Bachelor’s degree Basic understanding of global medical device regulations such as ISO 13485, FDA QSR, 21 CFR 806 or local regulatory reporting requirements.
- Experience required: 4-6 years' experience. Medical Device and/or other regulated industry (Pharma, IVD) experience
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