Regulatory Program Manager I

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Job description

Key Qualifications:

BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience

3+ years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred.

Thorough knowledge of FDA's 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR, MDSAP

Direct experience with receiving, evaluating, and investigating complaints

Direct experience with submitting Adverse Event Reports to the US FDA

Experience developing and implementing post market processes for new product development activities

Proficiency in utilizing IMDRF codes and a comprehensive clinical grasp of handling complaints

Ability to take initiative in an ambiguous and fast paced environment

Excellent verbal and written communication skills with ability to lead meetings

Strong organizational, time management, and influence skills

Experience with risk management is highly preferred

Experience with high volume complaints environment

In this key role of the Post Market Surveillance Specialist:

Be responsible for all administrative activities associated with the complaint handling process including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system.

Work with cross functional teams such as clinical, engineering and customer service groups to ensure product investigations are completed as well as maintain ongoing tracking and trending of complaints.

evaluate post market data and update risk management documentation

Evaluate complaint documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file.

Submit timely Adverse Event Reports to the US FDA, when appropriate

Conduct Post Market Surveillance activities to analyze post-market quality issues and trends

Identify potential issues to continuously improve product safety

Serve as the Subject Matter Expert to the Company for Complaints and Post Market Surveillance

Assist in the preparation and sending of post-market reports and submissions

Assist in different project work and process improvements as needed

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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