Associate Regulatory Affairs Specialist
Salary undisclosed
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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
Bold thinking. Bolder actions. We are Medtronic.
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Responsibilities may include the following and other duties may be assigned.
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
A Day in the Life
Bold thinking. Bolder actions. We are Medtronic.
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Responsibilities may include the following and other duties may be assigned.
- Execute submission strategy on-time
- Prepare dossier for regulatory submissions for Global Region
- Liaise with Operating Unit regulatory affairs and stakeholders to ensure alignment on submission plan
- Notify manager in a timely manner upon recognition of issues
- Respond to queries from FDA/MoH
- Keeps abreast of regulatory procedures and changes.
- Provide on-time status about projects under their scope and all applicable regulatory activities assigned
- Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
- At least 1-year regulatory experience in medical devices
- Experience in document interpretation, queries and workflow skills is an advantage
- Proficiency in Microsoft tools
- Excellent communication skills
- Ability to work as part of a team, good analytical and problem-solving skills
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
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
Bold thinking. Bolder actions. We are Medtronic.
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Responsibilities may include the following and other duties may be assigned.
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
A Day in the Life
Bold thinking. Bolder actions. We are Medtronic.
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Responsibilities may include the following and other duties may be assigned.
- Execute submission strategy on-time
- Prepare dossier for regulatory submissions for Global Region
- Liaise with Operating Unit regulatory affairs and stakeholders to ensure alignment on submission plan
- Notify manager in a timely manner upon recognition of issues
- Respond to queries from FDA/MoH
- Keeps abreast of regulatory procedures and changes.
- Provide on-time status about projects under their scope and all applicable regulatory activities assigned
- Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
- At least 1-year regulatory experience in medical devices
- Experience in document interpretation, queries and workflow skills is an advantage
- Proficiency in Microsoft tools
- Excellent communication skills
- Ability to work as part of a team, good analytical and problem-solving skills
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