Executive Job Description
In this function the Regulatory Manager "RA Manager" is responsible for all RA deliverables linked to the management of
new product development activities with focus on individualized prosthetics and digital dentistry.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU,
US, CAN and AUS. This will include the creation, review and/or approval of documents of the design control
process, development of the technical file and summary of technical documentation.
· The incumbent will be responsible for CE marking and supporting the US submission and monitoring submission
timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant
development/ improvement of product development and RA processes.
· Support international product registration by consulting the responsible RA Manager for international projects.
· Monitoring of legislative environment in main markets, i.e. EU, US, CAN and AUS and define and maintain an
overview of the regulatory requirements and changes in the areas if applicable.
· Assessing, approval and release of communication material (IFU, leaflets, brochures).
· Train and assist other departments to ensure continued compliance and timely market release.
· Development and execution of regulatory strategies for assigned development projects
· Support of product development in cross functional teams
· Creation, review and/or approval of documents of the design control process
· Accountable for regulatory compliance
· Support international product registration
· Assessment, approval and regulatory implementation of change requests
· Review and approval of product related labeling and marketing material
· Support SAP based reporting systems
· Monitoring legislative environment in relevant markets
· Training internally on relevant procedures and requirements
· Minimum 3-5 years experience in regulatory affairs within the Medical Device Industry
· Bachelors Degree (BS); Masters Degree (MS) is an advantage
· Strong knowledge of medical device legislation US, EU, AUS and CAN and corresponding guidelines
· Strong knowledge of quality system requirements specifically ISO 13485 and FDAs 21 CFR Part 820
· Documented working knowledge of product development processes in medical device industry
· Fluent in English
· Experience in preparation for and participation in notified body audits and FDA inspections
· Experience in managing cross functional projects and teams