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.
- 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.
- A minimum of 1 to 3 years of experience with regulatory / quality compliance within a pharma or medical device industry.
Other Required Skills:
- 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
RN degree or related medical or Risk Management required. MD is preferred.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor