Medical Compliance Specialist
Location: San Antonio, TX (78261)
Contract Length: 5 months (with possibility for extension)
*** Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status), able to pass a federal government background check and possess a valid U.S. passport.
- Prepares and maintains adverse event files and compiles adverse event investigation information.
- Investigates reports of potential adverse events and potentially reportable malfunctions and assesses potential reportable events to determine if regulatory filings are required.
- Maintains Regulatory databases and files.
- Plays a vital role in the preparation of various regulatory documents such as Medical Device and Vigilance reports.
- 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.
- 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.
- 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
- 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