Principal Regulatory Affairs Specialist - CSF
Principal Regulatory Affairs Specialist - CSFポジションにご関心をお寄せいただき、ありがとうございます。残念ながら、このポジションの募集はクローズしましたが、ここをクリックして1,349件の募集中のジョブを検索できます。
Must Have: Minimum Requirements
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
- Bachelor's Degree required. Engineering or Advanced degree desired.
- 7+ years of US/EU medical device regulatory affairs experience with Bachelor’s degree - OR -
- 5+ years of US/EU medical device regulatory affairs experience with an advanced degree
Nice To Have
- Degrees in Engineering or Regulatory Affairs preferred
- Expertise in 510(k)s, EU MDR Technical Documentation
- Knowledge of FDA and EU requirements
- Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (510(k)), Investigational Device Exemption (IDE), EU MDR, medical device submissions)
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
- Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations
- Regulatory Affairs Certification (RAC)
- Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
- Ability to compile data and summarize results
- Organized, efficient, process-oriented; high attention to detail
- Effective interpersonal/communication skills
- Works well under pressure in a dynamic timeline-driven environment
- Ability to effectively manage multiple projects and priorities
- Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
