2300 Berkshire Lane North Minneapolis, MN 55441 US
Ability to work with department peers and middle-management within the marketing, engineering, and manufacturing functional groups.
Nice To Have
- Understanding and / or experience with EUMDR regulation and the changes needed in medical devices to be compliant with new regulation
- Act as Voice of Quality function on deliverables needed to remediate products to EUMDR and provide guidance to other cross functional team members from Quality function point of view
- Interpret guidance documents and ISO Standards and apply them to EUMDR remediation scope of the company's Diabetes products.
- Broad understanding of how medical devices are approved in European Union such as interactions with Notified Body’s, Quality system requirements.
- Existing familiarity or ability to quickly come up to speed with other changing medical device regulations in the Europe region such as U.K. and Switzerland
When do you plan to start interviewing? ASAP
Will you be looking to hire and start ASAP or will the start date be delayed? Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? ASAP, it will be a hybrid working model.
Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required
Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.