Principal Regulatory Affairs Specialist
Medtronic
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**
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!
In this role, you will be driving the initiative ensuring appropriate licensing, marketing, and legal compliance of a range of our medical devices to control their safety and efficacy mainly for all products. This is a rare and incredible opportunity to enhance your skillset in supporting our market leading technology across a broad range of products.
**Responsibilities may include the following and other duties may be assigned:**
+ Possess expert knowledge of biological safety assessment in compliance with ISO 10993, FDA, and MFDS regulations.
+ Provide guidance in the development of products and selection of materials to ensure that released products meet Korea's biological safety requirements.
+ Utilize applicable standards, written procedures, statistical processes, and academic understanding of toxicology and biocompatibility principles to accomplish tasks.
+ Offer guidance, coaching, and training to RA teams for biocompatibility evaluations and/or toxicological risk assessments for regulatory submissions and compliance by analyzing, interpreting, and drawing conclusions from biocompatibility testing, extractable and leachable chemical characterization, and biological evaluations.
+ Maintain substantial knowledge of state-of-the-art principles and theories and may contribute to scientific literature and conferences.
+ Evaluate the biological effects of various materials used in medical devices, including potential toxicities and interactions with the human body.
+ Stay updated on regulatory requirements and guidelines related to biological evaluation report and toxicological assessments of medical devices.
+ Collaborate with experts in the global biocompatibility team.
**Required Knowledge and Experience:**
+ Bachelor’s degree required in medical/ biological science or equivalent field
+ Prior experience in a RA Specialist role is essential with min 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience, preferably medical devices industry
+ Good understanding and working knowledge of QARA Operations
+ Effective written and verbal communication skills in English and Korean languages
+ Strong ability to work well within a team and autonomously
+ Achievement oriented and ability to drive results with the highest quality standards
+ Computer skills (excellent knowledge of MS Office products)
+ Excellent problem-solving skills
+ Medical devices and class IV product licensing experience is highly regarded
+ Korea Good Manufacturing Practice experience is a great plus
**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 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 (http://www.medtronic.com)
**Welcome to our new Careers Site!**
**If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.**
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.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will…
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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