Senior Regulatory Affairs Specialist at Medtronic

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Medical, Mechanical, Electrical, Life Science or other healthcare related majors
7+ years experience in Regulatory Affairs (RA) role in medical device and/or pharmaceutical industry
Works independently with general supervision on larger, moderately complex projects/assignments
Contributes to the completion of project milestones
Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
Ability to quickly establish credibility with all levels of customer base
Communicates primarily and frequently with internal contacts; contacts others to share information, status, needs and issues to inform, gain input, and support decision making

Responsibilities

Support Design and Development Control activities with regulatory requirements, direction, tactics and strategies, working in a team environment with all organizational departments
Set up new process for entering new data in Regulatory Information Management System
Act as Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes
Keep abreast of regulatory procedures and changes
Provide requested regulatory data and documents to support tenders
Lead in development/maintenance of regulatory files, data, records, and reporting systems for systematic retrieval of information
Prepare, review, file, and support premarket documents for global registrations for assigned projects
Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects
Prepare document packages for international regulatory submissions from all areas of company, internal audits and inspections
Compile all materials required in submissions, license renewal and annual registrations
Recommend changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance
Monitor and improve tracking/control systems
Direct interaction with regulatory agencies on defined matters
Develop Regulatory Strategies for new or modified products for assigned projects
Monitor and provide information pertaining to impact of changes in the regulatory environment
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters
Document, consolidate, and maintain oral and written communication with health authorities
Prepare internal documents for modifications to devices, when appropriate
Author and/or review regulatory procedures and update as necessary
Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments

Skills

Regulatory Affairs

Regulatory Submissions

RIM

Regulatory Strategy

Premarket Documents

Global Registrations

Internal Audits

Inspections

Labeling Compliance

Manufacturing Compliance

Clinical Protocols

Regulatory Tracking Systems

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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