JOB SUMMARY

Viscot Medical, a global medical device company, is seeking an experienced Regulatory Affairs Specialist. Reporting to the Director of Quality, the Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements.

QUALIFICATIONS

• Bachelor’s degree in STEM AND a minimum of 2 years of related experience.
• Working knowledge of ISO 13485 or ISO 9001
• Working knowledge of 21 CFR 800 for Medical Devices and EU MDR
• Experience with pre- and post-market medical device submissions support such as 510(k), IDE., PMA preferred
• RAPS certification: RCC or RAC is preferred
• ASQ certification: CQE or CQA is preferred
• Proficiency in MS Word and Excel
• Analytical thinking with clear and effective verbal and written communication skill
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities

• Respond to internal and external requests for compliance and regulatory matters
• Ensure compliance of QMS as Document Control and CAPA manager
• Work with Quality management, product development, and operations to assist with interpretation and compliance of applicable standards (e.g. ISO, FDA, EU MDR)
• Provide country specific regulatory support
• Liaise with our Authorized Representatives in various global regions
• Knowledge of Quality processes to support audit functions
• Assist with shipping authorization documentation for assigned geographies
• Ability to perform as team member for multiple concurrent tasks with accuracy
• Provide support to Quality Department for change or improvement initiatives
• Analyze and present data to functional managers
• Other duties as assigned