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.
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.