Medical device Company is looking to add to the team.
The Medical Compliance Specialist is responsible for:
Coordinating all activities related to global adverse event reporting
Investigating and assessing complex medical events associated with adverse events and potentially reportable malfunctions including the gathering and documentation of key medical information from medical professionals to complete medical investigations and determine if regulatory filings are required
Managing timelines according to global reporting regulations
Maintaining and managing Regulatory databases and files and participates in updates to databases or as a key opinion leader on project teams
Preparing and completing regulatory documents such as Medical Device reports, Vigilance reports, Health Hazard Evaluations, product risk management files and any other reports
Maintaining a strong working relationship with agencies, notified bodies, and organizations that govern products
Gathers, compiles, and completes complex adverse event investigations within regulatory timelines including direct contacts with medical professionals to gain medical information related to adverse events.
Provides medical expertise for Health Hazard Evaluations in coordinates with other departments to ensure timeliness and compliance.
Manages and maintains adverse event files, MDRs (Medical Device Report), vigilance reports, and other reports.
Facilitates organizes, and manages cross-functional teams to complete and submit regulatory files and documentation including ad hoc Food and Drug Administration (FDA) submissions, international submissions, literature reviews, and annual reports.
Researches, obtains and applies knowledge to interpret regulatory standards and guidance documents applicable to Co.products.
Participates/facilitates interdepartmental knowledge sharing and information gathering through regulatory presentations, summary reports, and meeting attendance in preparation for submissions to regulatory agencies.
Performs a key interfacing role in corporate, departmental, and regulatory audits.
Participates on risk management review board to approve product risk management files.
Bachelors in Medical, Engineering, Life Sciences or related degree
At least 5 years experience in Regulatory, Quality compliance within the pharma or medical device industry
Experience with Microsoft Office Applications including Word, Excel, and Outlook
Experience in the medical profession or regulatory risk management.
Experience in regulatory requirements for medical devices
Experience in quality control, quality assurance, and risk management.
Experience using/creating databases and prepare documents.
Demonstrated presentation and communication skills
At least 5 years exp. with global medical device regulations
Experience dealing with diverse groups including medical professionals at all levels.
Z&A Recruiting - 18 months ago