SEA Quality and Regulatory Affairs Lead

Medtronic; Petaling Jaya; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading global healthcare technology company is seeking a dedicated individual to manage regulatory submissions and compliance. Responsibilities include directing documentation and leading project teams. The ideal candidate has a Bachelor's degree in a relevant field, with significant managerial experience. This role offers a competitive salary and comprehensive benefits, contributing to a mission-driven environment that values healthcare access and equity.

Benefits

Competitive salary

Flexible benefits package

Short-term incentive plan

Qualifications

• Minimum of 7 years of relevant experience with 5+ years of managerial experience.
• Broad management knowledge to lead project teams.
• Mastery level knowledge and skills within a specific technical or professional discipline.

Responsibilities

• Directs or performs documentation for regulatory submissions.
• Leads materials compilation for submissions and renewals.
• Recommends changes for regulatory compliance.

Skills

Regulatory compliance

Project management

Team leadership

Education

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

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