Regulatory Affairs Specialist at Medtronic

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

B.TECH (Mandatory)
4 to 7.9 years of experience
Practical knowledge and demonstrated competence within job area, typically obtained through advanced education combined with experience
Ability to work independently with general supervision on larger, moderately complex projects/assignments
Specialized knowledge and skills normally acquired through advanced education

Responsibilities

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections
Leads or compiles all materials required in submissions, license renewal, and annual registrations
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
Monitors and improves tracking/control systems
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Recommends strategies for earliest possible approvals of clinical trials applications
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or direct the work of other lower level professionals
Sets objectives for own job area to meet the objectives of projects and assignments
Contributes to the completion of project milestones (may have some involvement in cross functional assignments)
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
Communicates primarily and frequently with internal contacts; contacts others to share information, status, needs, and issues
May provide guidance and assistance to entry level professionals and/or employees in Support Career Stream

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsInternal AuditsInspectionsLicense RenewalAnnual RegistrationsLabeling ComplianceManufacturing ComplianceMarketing ComplianceClinical ProtocolRegulatory TrackingRegulatory Procedures

Questions & Answers

Common questions about this position

What education and experience are required for the Regulatory Affairs Specialist role?

A B.TECH degree is mandatory, along with 4 to 7.9 years of experience and practical knowledge typically obtained through advanced education combined with experience.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture look like at Medtronic?

Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity while breaking down barriers to innovation in a connected, compassionate world.

What makes a strong candidate for this Regulatory Affairs Specialist position?

Strong candidates have a B.TECH degree, 4-7.9 years of experience, work independently with general supervision on moderately complex projects, and can contribute to project milestones while recommending process improvements.

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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