Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
This position works out of our location in St.Paul, Minnesota our AVD Vascular business unit. Our solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our products are also utilized by laboratory management to ensure efficiency in their operations.
Our client provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Role Overview:
- Perform assigned regulatory activities, including submissions/responses to country authorities.
Skills:
- Working knowledge in EU MDR.
- Regulatory Change Assessment proficiency.
- Experience with US and EU medical device submissions.
- Support in internal and external inspections.
- Cross-functional collaboration in a matrixed environment.
- Experience in continuous improvement activities.
- Strong oral communication and interpersonal skills.
- Proficient in technical writing.
- Excellent organizational ability, capable of managing multiple dynamic projects simultaneously.
- Proficiency in MS Office Suite, including an intermediate level with Excel using Pivot Tables, creating trackers, and monitoring with conditional formatting.
Duties:
- Collaborate with multiple business units to develop, update, and improve regulatory affairs processes.
- Assist in the implementation of regulatory affairs strategy and operations.
- Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop procedures for regulatory affairs in response to changes in the regulatory landscape, including EU MDR.
- Identify opportunities for regulatory affairs process improvement and drive changes to completion.
Daily Responsibilities:
- Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.
- Assist in the strategy implementation and operations for regulatory affairs activities, including the development of EU MDR Technical File submissions and responses to Notified Bodies.
- Maintain regulatory records and files.
- Review product changes and assess required EU MDR submissions/notifications.
Educational Requirements:
- BA Degree required, preferably in a science, engineering, or technology discipline.
Work Experience Requirements:
- 3-5 years of experience in Medical Device Regulatory Affairs.
Location:
- LCSI St. Paul building (1225 Old Hwy 8 NW, St. Paul MN 55112)
Interview Process:
- Initial phone screen followed by a Teams virtual interview.