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    Regulatory Affairs Specialist-Ii-Gurgaon

    Medtronic
    2+ years
    Not Disclosed
    Gurgaon
    10 Aug. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Join Medtronic for a Life-Long Career of Innovation and Healthcare Advocacy

    At Medtronic, embark on a career of continuous exploration and innovation, championing healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a connected, compassionate world.

    A Day in the Life

    Responsibilities:

    • Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
    • Compile all necessary materials for submissions, license renewals, and annual registrations.
    • Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
    • Monitor and improve tracking and control systems.
    • Stay informed about regulatory procedures and changes.
    • Interact with regulatory agencies on defined matters.
    • Recommend strategies for the earliest possible approvals of clinical trials applications.

    Specialist Career Stream:

    • Individual contributor with responsibility in a professional discipline or specialty.
    • Manage and deliver projects, working with other stakeholders to achieve desired results.
    • Mentor colleagues or direct the work of lower-level professionals.
    • Focus on delivering and overseeing projects from design to implementation, adhering to policies, and using specialized knowledge and skills.

    Differentiating Factors:

    Autonomy:

    • Productive individual contributor working independently with general supervision on moderately complex projects/assignments.

    Organizational Impact:

    • Set objectives for own job area to meet project and assignment goals.
    • Contribute to project milestones and may be involved in cross-functional assignments.

    Innovation and Complexity:

    • Address general problems that may require understanding of broader issues or other job areas.
    • Recommend enhancements in systems and processes to solve problems or improve job area effectiveness.

    Communication and Influence:

    • Communicate primarily with internal contacts.
    • External interactions are less complex and problem-solving in nature.
    • Share information, status, needs, and issues to inform, gain input, and support decision-making.

    Leadership and Talent Management:

    • Provide guidance and assistance to entry-level professionals and support career stream employees.

    Required Knowledge and Experience:

    • Practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience.
    • Baccalaureate degree (or equivalent for degrees earned outside the U.S. per 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

    Physical Job Requirements

    The statements above describe the general nature and level of work performed by employees in this position but are not exhaustive of all responsibilities and skills required.

    Benefits & Compensation

    Medtronic offers a competitive salary and flexible benefits package. Our commitment to employees is central to our values, recognizing their contributions and sharing in the success they help create. We provide a wide range of benefits, resources, and competitive compensation plans to support you at every career and life stage.

    About Medtronic

    We lead global healthcare technology and boldly tackle the most challenging health problems by finding innovative solutions. Our mission to alleviate pain, restore health, and extend life unites a global team of over 90,000 passionate individuals. As engineers at heart, we transform ambitious ideas into real solutions for real people, from the R&D lab to the factory floor to the conference room. We have the talent, diverse perspectives, and courage to engineer the extraordinary.

    Learn more about our business, mission, and commitment to diversity here.

    Medtronic is an equal opportunity employer committed to fostering an inclusive and diverse workplace.

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