Job Description :
Essential Duties and Responsibilities:
Review the EU-MDR Labeling Gap Assessment for regulatory compliance and provide review comments to Gap Assessors.
Prepare or compile the Regulatory documents according to Regulatory requirements.
Review and Approve Labeling Contents, SOP’s & Other related documents.
Co-ordinate and Guide the Offshore team members for the Complex Queries.
Respond to QA / RA team’s Questions.
Responsible for managing the development and release of all Product Labelling deliverables.
Responsible for maintaining excellent collaborative relationships with R&D, Product Marketing, Regulatory/Quality and other business functions.
Develop project Plans to meet the Regulatory and Business Unit’s deadlines.
Lead or Represent Regulatory Affairs in Project teams.
Requirements:
Strong knowledge of Medical Device Quality System Regulations & QMS (FDA 21CFR Part 820, ISO 13485, GDP, …)
Knowledge of EU Medical device regulation like
o Medical Device Directive 93/42/EEC
o Medical Device Regulation [EU MDR 2017/745]
Excellent written (Technical Writing) and Verbal communication skills
Good knowledge of Materials, Manufacturing process and capabilities
Ability to identify Compliance Risks and Escalate when necessary.
Change control Process (Tools: Track wise 8)
Project Management Skills (Tools: MS Project, Visio
Negotiation Skills
Pro-Active and Result oriented.