Principal 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
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.
Responsibilities may include the following and other duties may be assigned:
Must Have:
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.
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 90,000+ 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
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.
Responsibilities may include the following and other duties may be assigned:
- Preparing and submitting regulatory submission documents and evaluate the risk of proposed regulatory strategies and offer solutions, as applicable
- Ability to comprehend orthopaedic technical terminology or can reference literature for understanding
- Directs interaction with regulatory agencies as needed, including pre and post submission discussions and negotiations, to ensure timely product approval
- Advise internal stakeholders regarding current/pending guidance, regulations to ensure regulatory strategy is in alignment with company objectives and ensures standard and process compliance.
- Communicate application progress to internal stakeholders and with regulatory agencies as needed.
- Works collaboratively with regulatory and cross functional business partners to achieve and maintain compliance with regulatory requirements
- Localized Advocacy to new/upcoming regulation and in partnership with APACMed (Asia Pacific Medical Technology Association), Local Association and Indonesia RA (Regulatory Affairs) Forum.
Must Have:
- Bachelor’s degree in Pharmaceutical
- Minimum of 6-8 years’ experience in Regulatory Affairs within the medical device or healthcare industries
- Excellent knowledge and experience with medical device and regulatory requirements
- Ability to maintain responsibility for process or key area of Regulatory
- Excellent research and analytical skills
- High sense of urgency and commitment to execution
- Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
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.
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 90,000+ 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
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