Sr Regulatory Affairs Spec at Medtronic

Ho Chi Minh City, Ho Chi Minh City, Vietnam

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Baccalaureate degree (or equivalent for non-US degrees per 8 C.F.R. § 214.2(h)(4)(iii)(A)) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
Practical knowledge of project management (may have)

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 renewals, 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
Works independently under limited supervision to determine and develop approach to solutions
Coaches and reviews the work of lower-level specialists; may manage projects/processes
May be responsible for entire projects or processes within job area; contributes to work group objectives through building relationships and consensus
Makes improvements of processes, systems, or products to enhance performance of the job area
Provides in-depth analysis and recommendations on process improvements
Communicates with senior internal and external customers and vendors; exchanges information to achieve objectives and influence decision-making
May provide guidance, coaching, and training to other employees within job area; may manage projects requiring delegation and review of others' work

Skills

Regulatory Submissions

Document Coordination

Internal Audits

Inspections

Labeling Compliance

Manufacturing Compliance

Marketing Compliance

Clinical Protocols

Regulatory Tracking

Regulatory Procedures

Agency Interaction

Clinical Trials Approvals

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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