Principal Regulatory Affairs Specialist / Manager

Übersicht

JOB DETAILS Must-have/Qualifications:

• Bachelor's Degree or related technical or scientific discipline. Master's degree in Regulatory preferred or RAPS certification.
• 5-10 years' experience in regulatory affairs within the medical device industry
• Strong experience in EU Regulations (Medical Device directives (93/42/EC) and EU MDRs) required
• Experience in FDA product submissions (IDE, PMA, 510k) required
• Experience in writing/maintaining CE Technical Files preferred
• Experience with ISO 13485:2016 and ISO 14971 required.
• Excellent problem solving, decision-making, and root cause analysis skills are required.

DUTIES & RESPONSIBILITIES

• Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
• Provide guidance and approval regarding regulatory strategies and approaches.
• Develop, Maintain and update regulatory documents such as technical files for CE
  marking, device master records, GSPR checklist, risk analysis, and design history files.
• Participate and Support new product development teams to provide regulatory support to
  the project.
• Represent regulatory affairs on engineering and R&D product development project teams
  to ensure all regulatory requirements are met through the development process and defining the requirements for regulatory submissions of products on international and domestic markets.
• Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging and notifying regulatory agencies and NB of substantial changes.
• Support post market activities and reportability to regulatory agencies.
• Required to support communication with FDA and the Notified Body, preparing responses
  to questions or deficiency letters from regulatory agencies.
• Support and implement transition plans to new MDR regulations
• Required to maintain MDR system and compliance once implemented
• Participate and represent regulatory affairs during FDA and NB site audits.