Post Market Surveillance (Corrections and Removal Specialist) at APN Software Services, Inc.

Job title: Post Market Surveillance (Corrections and Removal Specialist)
Duration: 18 Months
Location: Pittsburgh, PA 15206 (hybrid)

Key Areas of Responsibilities:
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.

Operational:
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

Job Overview:
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.

Markets:
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.
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 scope 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

EDU & Training Requirements: 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