Principal Regulatory Affairs Specialist

서울시
정규직
풀타임

1일 전

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 fieldPrior 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 industryGood understanding and working knowledge of QARA OperationsEffective written and verbal communication skills in English and Korean languagesStrong ability to work well within a team and autonomouslyAchievement oriented and ability to drive results with the highest quality standardsComputer skills (excellent knowledge of MS Office products)Excellent problem-solving skillsMedical devices and class IV product licensing experience is highly regardedKorea Good Manufacturing Practice experience is a great plusPhysical Job RequirementsThe 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 & CompensationMedtronic 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 MedtronicWe 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

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