SR. Manager

4 days ago

Delhi, Delhi, India Zoot Systems Full time ₹ 9,00,000 - ₹ 12,00,000 per year
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."

  • Sales Manager

    2 weeks ago

    Delhi, Delhi, India SR INFRA Full time ₹ 87,000 - ₹ 12,00,000 per year

    Job Title: Sales ManagerCompany: SR Infra AsiaIndustry: Real EstateYour Key Responsibilities:Lead and manage the sales team to achieve monthly and annual sales goals.Develop new business opportunities and convert leads into successful deals.Build and maintain long-term relationships with clients and channel partners.Conduct property presentations, client...

  • Sr. Manager Bid

    5 days ago

    Delhi, Delhi, India Uneecops Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    As a candidate for this role, you will be responsible for managing bids at Manager/ Sr. Manager / AGM/ GM level in the organization. - Manage bids at Manager/ Sr. Manager / AGM/ GM level If you are interested in this opportunity, please share your resume with Priyanka Chaudhary at hidden_email you.,

  • Sr. Manager

    6 days ago

    Delhi, Delhi, India Tata Capital Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    DescriptionJob PurposeThe Sr. Manager Product will support the National Product Manager in overseeing the product lifecycle, from ideation and development to launch, ongoing management, and eventual retirement. This role involves close collaboration with various internal teams to ensure the alignment of product strategies with business objectives, regulatory...

  • Sr. Account Manager

    24 hours ago

    Delhi, Delhi, India Spectra Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionSpectra is India's trusted business connectivity partner, empowering over 10,000 customers, including offices, hotels, PGs, and campuses, with high-speed, reliable internet. We specialize in dedicated leased lines and Pro-Fi solutions, offering dependable connectivity tailored to unique business needs. Our customer-first approach, combined...

  • Sr. Sales Manager

    1 week ago

    Delhi, Delhi, India Indigotex Pvt. Ltd. Full time ₹ 16,00,000 per year

    Join Indigotex – whereinnovation meets sustainabilityWe're hiring aSr. Sales Managerto lead sales for ourwool denim and premium sustainable fabrics.If you've got 7+ years in fabric exports, solid industry contacts, and a passion for smart textiles — let's talk Apply: Package: ₹16 LPA (Negotiable) Location: IIT Delhi R&I Park

  • Manager/Sr. Manager-Costing

    2 weeks ago

    Delhi, Delhi, India Blacklead Infratech Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Manager/Sr. Manager Costing (pre-bid)Qualification- B.Tech-Civil with 5+ years experience. Preferred from Government Engineering College.Key responsibilities (not limited to)Tender Management: Review RFPs, prepare and submit tenders, ensuring compliance with client specifications and regulations.Cost Estimation: Develop detailed cost estimates covering...

  • Sr Account Manager

    3 days ago

    Delhi, Delhi, India Heads Quest Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Description:Role: Sr. Account ManagerWork Location: DelhiReporting to : Regional Manager Roles & Responsibilities:Customer Service Install, commission, maintain Unify equipment,Provide training to customers on applications and operational aspects, act as information channel between customer and organization,Coordinate with vendors, seek technical...

  • Sr. Architect

    1 week ago

    Delhi, Delhi, India Design Consortia Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This is a full-time on-site role for a Sr. Architect at Design Consortia, located in Delhi, IndiaThe Sr. Architect will be responsible for overseeing architectural design processes, ensuring project integration, managing project timelines, and collaborating with other professionals to execute design solutionsDay-to-day tasks include client consultations,...

  • Sr. Account Manager

    2 weeks ago

    Delhi, Delhi, India Avian We. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Requisitioned Position TitleSr. Account ManagerPosition Reports ToSr. Account Director/Group Business DirectorHiring Location:New DelhiTotal Experience:6 - 8 YearsOverview –Manage & lead the communication portfolio for one of our Leading MNC clients in the Lifestyle beat. The ideal candidate is an experienced communicator who thrives in an environment...

  • Sr. Manager – Electrical

    4 days ago

    Delhi, Delhi, India Dhruv Corporate HR Solutions Full time ₹ 14,00,000 - ₹ 17,00,000 per year

    Job Description:Job Description – Sr. Manager, Electrical & Automation Design & DevelopmentPosition: Sr. Manager – Electrical & Automation Design & Development Location: Sari, Ahmedabad Reporting To: Vice President – Corporate R&D Compensation: ₹14–17 LPA (depending on candidate profile & experience)About the RoleWe are seeking an experienced and...