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SEA Quality and Regulatory Affairs Lead

Medtronic

SEA Quality and Regulatory Affairs Lead

full-timePosted: Jan 15, 2026

Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • 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.

Required Knowledge and Experience: 

  • Bachelor’s degree in Engineering, Business, Healthcare Management, or a related field.

  • Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience

  • Requires broad management knowledge to lead project teams in one department.

  • Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

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

Locations

  • Petaling Jaya, Selangor, Malaysia

Salary

Estimated Salary Rangemedium confidence

120,000 - 185,000 USD / yearly

Source: AI Estimation

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Broad management knowledge to lead project teamsintermediate
  • Mastery level knowledge and skills within a specific technical or professional disciplineintermediate
  • Broad understanding of other areas within the job functionintermediate

Required Qualifications

  • Bachelor’s degree in Engineering, Business, Healthcare Management, or a related field (experience)
  • Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience (experience)

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

Benefits

  • general: Competitive Salary
  • general: Flexible Benefits Package
  • general: Wide range of benefits, resources, and competitive compensation plans
  • general: Short-term incentive called the Medtronic Incentive Plan (MIP)

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Medtronic logo

SEA Quality and Regulatory Affairs Lead

Medtronic

SEA Quality and Regulatory Affairs Lead

full-timePosted: Jan 15, 2026

Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • 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.

Required Knowledge and Experience: 

  • Bachelor’s degree in Engineering, Business, Healthcare Management, or a related field.

  • Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience

  • Requires broad management knowledge to lead project teams in one department.

  • Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

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

Locations

  • Petaling Jaya, Selangor, Malaysia

Salary

Estimated Salary Rangemedium confidence

120,000 - 185,000 USD / yearly

Source: AI Estimation

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Broad management knowledge to lead project teamsintermediate
  • Mastery level knowledge and skills within a specific technical or professional disciplineintermediate
  • Broad understanding of other areas within the job functionintermediate

Required Qualifications

  • Bachelor’s degree in Engineering, Business, Healthcare Management, or a related field (experience)
  • Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience (experience)

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

Benefits

  • general: Competitive Salary
  • general: Flexible Benefits Package
  • general: Wide range of benefits, resources, and competitive compensation plans
  • general: Short-term incentive called the Medtronic Incentive Plan (MIP)

Target Your Resume for "SEA Quality and Regulatory Affairs Lead" , Medtronic

Get personalized recommendations to optimize your resume specifically for SEA Quality and Regulatory Affairs Lead. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "SEA Quality and Regulatory Affairs Lead" , Medtronic

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score
Quiz Challenge

Answer 10 quick questions to check your fit for SEA Quality and Regulatory Affairs Lead @ Medtronic.

10 Questions
~2 Minutes
Instant Score

Related Books and Jobs

No related jobs found at the moment.