Regulatory Affairs Specialist

JOB RESPONSIBILITIES

• Prepares regulatory submissions to regulatory authorities within the EMEA region. Assist with determination of regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
• Participates on various teams to define regulatory requirements for countries in the EMEA region, and process international submissions.
• Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation. Interacts with various levels of management, external agencies and companies.
• Assist with developing, maintaining and analyzing department systems and provides training when needed. Remains current on developing regulations and revises systems as necessary.
• Participates in and assists with Competent Authority inspections, Notified Body Audits and other governmental inspections as directed or as applicable.
• Performs other related duties and tasks, as required.

EXPERIENCE REQUIRED

• Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience.
• Knowledge of the Medical Devices Directive (93/42/EEC, as amended), Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
• 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.