SEA Quality and Regulatory Affairs Lead

Medtronic; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

A global healthcare technology company in Malaysia is seeking a regulatory compliance manager with at least 7 years of experience and strong leadership skills. Responsibilities include coordinating and preparing regulatory submissions, leading project teams, and monitoring tracking systems. Candidates should hold a relevant Bachelor's degree and possess a mastery level of their discipline. The position offers competitive salary and benefits within a supportive culture.

Benefits

Competitive salary

Flexible benefits package

Medtronic Incentive Plan (MIP)

Qualifications

• Minimum of 7 years of relevant experience with 5+ years of managerial experience.
• Typically has mastery level knowledge and skills within a specific technical discipline.
• Broad understanding of other areas within the job function.

Responsibilities

• Directs or performs coordination and preparation of regulatory document packages.
• Leads compilation of materials for submissions and license renewals.
• Monitors and improves tracking/control systems.

Skills

Leadership

Regulatory compliance knowledge

Project management

Education

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

Job description

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-thHash 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