Medical Compliance Specialist (Wound Therapeutics RN/LVN)

Published
April 15, 2021
Location
San Antonio, TX
Category
Job Type

Description

Medical Compliance Specialist

Location: San Antonio, TX (78261)

Contract Length: 12 months (with possibility for extension)

Work Schedule: Monday-Thursday 8AM-5PM, Friday is a 6 hour day

The Medical Compliance Specialist I (MCS I) prepares and maintains adverse event files and compiles adverse event investigation information. The MCS I investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required. The MCS I maintains Regulatory databases and files. The MCS I plays a vital role in the preparation of various regulatory documents such as Medical Device and Vigilance reports.

Principle Responsibilities (essential job duties and responsibilities):

  • Gathers and compiles adverse event investigation information through employee and customer contact including phone solicitations to healthcare professionals.
  • Coordinates adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion.
  • Manages and maintains adverse event files and MDR (Medical Device Report) tables.
  • Creates, organizes and manages regulatory files and documentation including Food and Drug Administration (FDA) submissions, international submissions, annual reports, and ad hoc reports.
  • Conforms to and enforces KCI policies and procedures as related to job function.
  • Performs a role in corporate, departmental, and regulatory audits to record activities as may be deemed suitable and assigned by management.
  • Participates in other duties as assigned.

Minimum Qualifications:

  • Bachelor of Medicine degree or Bachelor of Science degree in Nursing or other related medical degree (e.g. risk management)
  • A minimum of 1 year of experience with regulatory / quality compliance within a pharma or medical device industry.

Other Qualifications:

  • Experience in the medical profession or regulatory risk management
  • Excellent computer skills including use of Microsoft Office business software and search engines
  • Excellent oral communication skills
  • Excellent medical/technical writing skills
  • Ability to use/create databases, spreadsheets and prepare documents.
  • Proficiency with Microsoft Office business software and use of information databases
  • Keyboarding skills - >35 WPM
  • Ability to use databases and prepare documents
  • Proven ability to work and maintain a positive environment with peers, management, all KCI employees and customers
  • Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business and medical judgement
  • Proven ability to communicate effectively, orally, and in writing
  • A minimum of 1 year of experience with advanced wound therapeutics product/process knowledge

Preferred Qualifications:

  • Experience with global medical device regulations
  • Preference dealing with diverse groups including medical professionals at all levels
  • Knowledge/experience in quality control, quality assurance, and risk management preferred
  • Ability to work individually and as part of a team
  • Ability to work effectively with all employees and external business contacts while conveying a positive attitude
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