We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

Keywords: Regulatory affairs, RA with CE and international experience, Project management skill is preferred, US and EU submissions including PMA, 510k, IDE, medical device Industry exp.

Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Monitor trade association positions for impact on company products
• Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Recruit; develop and mentor regulatory professionals
• Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile; prepare; review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies and update internal stakeholders
• Monitor applications under regulatory review
• Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
• Ensure compliance with product post marketing approval requirements
• Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
• Actively contribute to the development and functioning of the crisis/issue management program
• Provide regulatory input for product recalls and recall communications
• Report adverse events to regulatory agencies and internal stakeholders
• Review and approve advertising and promotional items to ensure regulatory compliance

Thanks and Regards,

Mohammed Ilyas,

PH - 229-264-4029.

All your information will be kept confidential according to EEO guidelines.