2 Jobs in Rice, MN
Medtronic is Hiring a Regulatory Affairs Specialist Near Rice, MN
The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market, provides advice on regulatory requirements, prepares submissions, and negotiates their approval. The RA Specialist also assists with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations.
Responsibilities may include the following and other duties may be assigned.
- Prepare FDA, European, and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with the supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
- Prepare regulatory strategies/plans and compliance requirements. Provide ongoing support to project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
- Provide business and product information to enable the development of strategies and requirements and communicate that information to the Project teams.
- Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
- Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.
- Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
- Provide regulatory product portfolio analysis and review with other functional resources, such as Marketing, Global Supply Chain, etc. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Work under general supervision following established procedures. Independently determines and develops an approach.
- Frequent inter-organizational contact and some external contacts.
- Keeps current on global directives, harmonized standards and procedures, and communicates changes that may affect cross-functional areas.
- Other tasks, as required
- Bachelor's degree required
- Minimum of 2 years of regulated industry experience.
- Experience working in a regulated biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
- 4 years of medical device industry experience
- In-depth experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive/ EU Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Experience with Class III medical devices (PMA) and/or active implantable devices
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Computer skills: MS Office, MS Project, Adobe Acrobat, and Agile
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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which allows you to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here .
The provided base salary range is used nationally in the United States (except in Puerto Rico and specific CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Job Summary
Full Time
Medical Technology
$100k-128k (estimate)
02/17/2024
06/10/2024
medtronic.com
WASHINGTON, DC
>50,000
1949
Public
PETER B SLONE
$3B - $5B
Medical Technology
Related Companies
About Medtronic
Medtronic is a medical technology and services firm that manufactures devices and therapies to treat for chronic diseases.
The job skills required for Regulatory Affairs Specialist include Regulatory Affairs, Supply Chain, Innovation, ISO, Time Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.
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