Regulatory Affairs Specialist - Medical Device
- Contract Type
- Assist with determination of EMEA 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 EU international submissions within the EMEA region.
- Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities.
- Interacts with various levels of management, external agencies and companies.
- Assists with analysis and making recommendations regarding complaints received by the company and whether they are MDR, MPR or Vigilance reportable; participates in complaint related meetings.
- 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 FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Performs other related duties and tasks, as 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 U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.
- Knowledge of the international regulatory environment and their regulations within the EMEA region
- 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.