Zoot Systems is a Current 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 AffairsEmployment Type – Full timeWork Experience – 10+ Year in a similar roleLocation – 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."

📌 SR. Manager (Medical Device)- Regulatory Affairs (Delhi)
🏢 Zoot Systems
📍 Delhi