SR. Manager

4 days ago

Delhi, Delhi, India Zoot Systems Full time
Zoot Systems is a New Delhi, India based company. For years, it has been our continuous endeavours to understand Client quality-conscious discerning business needs and to successfully meet those. We specialize in the creation of high-quality I.T./Non-I.T. based HR Solutions, Recruitment, and RPO to companies of all sizes resulting in better, faster, and more meaningful results. With a focus on state-of-the-art I.T. /Non-I.T. services, Zoot Systems developed a niche and expertise in Staffing, IT Recruiting, Non-IT Recruiting, and Offshore Outsourcing services.
I have an urgent position with one of my Client; below are the Job Details kindly take a look & let me know your comfort level too.
Job Title: SR. Manager (Medical Device)- Regulatory Affairs Employment Type – Full time Work Experience – 10+ Year in a similar role Location – Dwarka (2 mints walk metro station)
Responsibilities: EU-MDR 2017 Compliance:
  • Lead the preparation and maintenance of technical documentation, including the Technical File and Design Dossier, according to EU-MDR 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
  USFDA Registration:
  • 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.
  ISO 13485 Quality Management:
  • 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 14971-compliant risk management processes across the organization.
Regulatory Strategy Development:
  • 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.
Technical Documentation and Submissions:
  • 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.
Cross-functional Collaboration:
  • 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 post-market surveillance.
Regulatory Intelligence and Compliance Monitoring:
  • 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.
Notified Body and Regulatory Agency Relations:
  • 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.
Requirements:
  • Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
  • Minimum 7 years of progressive experience in regulatory affairs within the medical device industry.
  • In-depth 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.
  • Detail-oriented mindset with analytical problem-solving abilities.
  • Experience in developing quality manuals, SOPs, and technical documentation."

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