SR Manager Medical Device- Regulatory Affairs

• Lead the preparation and maintenance of technical documentation including the Technical File and Design Dossier according to EUMDR 2017 requirements.
• Collaborate with teams to ensure completeness and accuracy of technical documentation for product registrations and conformity assessments.
• Faced the audit of the notified body

• Manage the preparation and submission of 510(k) applications IDEs (Investigational Device Exemptions) and premarket approval (PMA) submissions to the USFDA.
• Provide strategic guidance on regulatory pathways for product clearance and market authorization in the United States.
• Liaise with USFDA officials during inspections audits and communications.

• Develop and maintain the Quality Management System (QMS) including the preparation of the Quality Manual and Standard Operating Procedures (SOPs) in compliance with ISO 13485 requirements.
• Oversee internal audits CAPA processes and training programs to ensure adherence to quality standards and regulatory requirements.
• Implement ISO 14971compliant risk management processes across the organization.

• Formulate global regulatory strategies for product registrations and approvals in key markets considering EUMDR USFDA and other applicable regulations.
• Stay abreast of the evolving regulatory landscape and advise on regulatory implications for new product development projects and lifecycle management.

• Lead the preparation and maintenance of regulatory submissions technical files design dossiers and other documentation required for product approvals.
• Ensure timely and accurate submission of regulatory documents to authorities and notified bodies.

• Collaborate closely with R&D Quality Assurance Manufacturing and Marketing teams to integrate regulatory requirements into product design development and commercialization processes.
• Provide regulatory guidance and support throughout the product lifecycle from concept to postmarket surveillance.

• Monitor changes in regulations guidelines and standards affecting medical devices and IVDs.
• Assess the impact of regulatory changes on existing products and ongoing projects and implement compliance initiatives as necessary.

• Build and maintain relationships with notified bodies regulatory agencies and industry associations.
• Represent the company in regulatory interactions meetings and audits to facilitate product approvals and regulatory compliance.

• Bachelors degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum 7 years of progressive experience in regulatory affairs within the medical device industry.
• Indepth knowledge and experience with EUMDR 2017 USFDA regulations (including 21 CFR Part 820) and ISO 13485 standards.
• Proven track record of successful regulatory submissions and approvals.
• Strong project management skills with the ability to prioritize tasks and meet deadlines.
• Excellent communication and interpersonal skills for effective collaboration.
• Detailoriented mindset with analytical problemsolving abilities.
• Experience in developing quality manuals SOPs and technical documentation.

medical devices,dossier preparation,mdr