Role DescriptionResponsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, and EMEA region. Primary responsibilities are to ensure regulatory compliance for assigned product lines and countries. Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect companies’ business and products, assisting with Competent Authorities inspections, Notified Body audits, and other internal audits. Performs duties with limited input from management and/or senior members of the department.
Responsibilities* Determines regional regulatory pathways for various projects including product classification and type of regulatory submission or rationale required. * Participates on various teams to define regulatory requirements of international submissions, Technical Files or regulatory rationales. * Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation. * Prepares regulatory submissions to the Notified Body and other regulatory authorities and /or Distributors. * Interacts with various levels of management, external agencies and companies. * Analyzes and makes recommendations regarding field complaints. * Develops, maintains and analyzes department systems and provides training when needed. * Remains current on developing regulations and revises systems as necessary. * Participates in and assists with Competent Authorities inspections, Notified Body Audits and other inspections and audits as directed. * Assists with supervision of department staff, as directed. * Performs other related duties and tasks, as required.
Requirements* Education and experience of at least a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience. * Demonstrated knowledge of EMEA country regulations, U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc. * Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers. * Self-motivated, self-directing, strong attention to detail and excellent time management skills. * Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others. * Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
Other information* Regulatory submission/rationale preparation/publishing * Global Regulatory paths/strategies * Computer skills/internet research * Interpersonal/communication skills * Regulatory system development/training * Field Action coordination and reporting * Product development and change qualification processes
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.