Job Title:
MDR Vigilance Specialist II
Location:
Nanakramguda, Hyderabad, India
Job Type:
Full-time
Preferred Salary/Compensation:
Competitive Salary (exact amount not specified)
Work Mode:
On-site
Job Summary:
Medtronic, a global leader in healthcare technology, is seeking an MDR Vigilance Specialist II for its Hyderabad location. This role plays a vital part in the company's medical device surveillance program, ensuring compliance with international regulatory requirements, maintaining accurate adverse event data, and collaborating with internal and external stakeholders. Ideal for professionals with a strong background in pharmacovigilance, regulatory affairs, or healthcare compliance, this opportunity offers the chance to contribute to patient safety and product excellence in the medical device industry.
Key Responsibilities:
Monitor medical device surveillance programs, including adverse event intake, evaluation, and follow-up.
Develop protocols for data processing in line with government regulations.
Ensure accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data.
Review and analyze clinical databases to extract and unify ADE data for internal and regulatory purposes.
Liaise with internal teams and external partners to meet regulatory reporting standards.
Deliver and oversee assigned projects independently, adhering to organizational policies.
Communicate status updates, project needs, and outcomes to stakeholders effectively.
Provide guidance to entry-level professionals as needed.
Required Skills & Qualifications:
Bachelor’s degree in a relevant field (as per 8 C.F.R. § 214.2(h)(4)(iii)(A)) with a minimum of 2 years of relevant experience, or an advanced degree with no required experience.
Practical knowledge of medical device vigilance or pharmacovigilance processes.
Strong understanding of MDR regulations and ADE data management.
Ability to manage moderately complex projects independently.
Effective communication and problem-solving skills.
Ability to collaborate with cross-functional teams.
Perks & Benefits:
Competitive salary and flexible benefits package.
Private Pension Plan and transport allowance.
Medical and dental insurance coverage.
Life insurance and Gympass membership.
Childcare assistance and pharmacy discounts.
Employee Stock Purchase Program (ESPP).
Educational and language development subsidies.
Holiday break program and Short Fridays (early finish at 2 PM).
Paid family leave and generous parental policies.
Company Description:
Medtronic is a global healthcare technology innovator dedicated to advancing medical solutions that alleviate pain, restore health, and extend life. With a team of over 95,000 employees worldwide, Medtronic is committed to improving patient care through bold ideas and engineering excellence.
Call to Action:
Ready to make an impact in medical device vigilance? Apply now to join Medtronic's regulatory team and contribute to the future of healthcare innovation.
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