Partners with the Quality and Regulatory Team, Corporate Engineering, Sales and Marketing to develop cohesive registration planning for existing products, new products and product and facility changes.
Provides local support for registration and licensing requirements as they apply to products and services of the company both domestically and internationally, as well as facility licensing activities pertinent to EU/EMEA.
Reviews and approves labeling for compliance, including all communications to trade publications, news media release, sales presentations and technical bulletins specific to EU/EMEA
Collaborates and assists Global Regulatory (European Authorized Representative) to support product compliance internationally.
Identifies specific EMEA Regulatory legislation, develops strategies for compliance, and provides monthly updates of upcoming changes.
Maintains the list of relevant Harmonized Standards.
Working with the Global Quality and Regulatory Affairs to ensure international vigilance processes and management for Product Surveillance (distributor and direct sales and service) are relevant, effective, and maintained.
Executes all associated activities for compliance to EU/EMEA vigilance reports reporting regulations.
Provides key support for EU business locations and maintains electronic files and access to Quality and Regulatory technical documentation and product labeling to support tenders and Quality and Regulatory requests.
Other duties as assigned.
Bachelor’s Degree required, preferably in a Science or Engineering field.
Professional certifications (i.e., CQM/OA, RAB, RAPS) preferred
Minimum of 4 years of experience managing complaint management processes in the medical device or related industry required (e.g., QSR (21 CFR 820) and ISO/EC (MDD, ISO 13485)).
Knowledge and understanding of FDA regulations and reporting requirements for medical device complaints, including MDR reports required.
Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations strongly preferred.
Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601 strongly preferred.
Experience interacting with Health Care Professionals, patients, and consumers to complete and close complaint investigations strongly preferred.
Experience with complaint management software systems and databases preferred.
Basic understanding of statistical tools strongly preferred