Plymouth Categories:
Principal Regulatory Project Manager superDimension
THIS JOB HAS EXPIRED
Department or Division: RA/QAReports to: Vice President, RA/QA
Summary Statement
Direct the company?s regulatory programs and strategies for new product development, new regulatory submissions and ongoing registration requirements. Promote continuous improvement of systems, products and services. Establish and maintain RA systems that are in conformance with international and local requirements.
Position Responsibilities
ESSENTIAL FUNCTIONS:
Define, communicate and gain executive support for the company's new product development regulatory strategy.
Develop RA management programs which are best in class and result in improved quality, time to market and cost effectiveness.
Develop cross functional collaborative relationships with Operations, R&D, and others to facilitate engagement, teambuilding, best practice sharing, critical thinking and innovative problem solving.
Develop the regulatory skills and resources for all employees.
Manage and drive accountability for process/product improvements.
Prepare, submit, and support 510(k) and other regulatory filings.
Design and lead effective regulatory processes including procedures, documentation systems, tools, metrics and measurable improvements that are required to meet quality system standards/product approval submission activities.
Develop, communicate and drive standard reporting/analysis tools to improve the business. Develop continuous improvement learning processes.
Represent superDimension to the customers, government agencies, global regulatory bodies, suppliers and others as appropriate.
Ensure compliance for all laws and regulations are met.
Manage teams to the highest levels of performance and superior leadership.
Qualifications
Experienced with application of FDA and ISO quality standards in a government regulated healthcare industry
Ability to quickly grasp technology, medical applications, and applicable regulations/standards
Ability to create and effectively communicate regulations/standards
Ability to positively influence groups across an organization to embrace a common philosophy
Ability to manage and execute on multiple, critical projects simultaneously
Strong ethics to escalate issues in the face of competing corporate priorities
Working knowledge of US and international regulations and standards
Ability to travel 20% of time
MS Word, Excel, Project, familiar with the internet
Education
Bachelor's degree in technical or scientific field or equivalent work experience.
8-10 plus years experience in Regulatory environment
Demonstrated experience in preparing 510(k).
| Location: | Plymouth, MN United States |
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THIS JOB HAS EXPIRED
superDimension
Investors: Gemini Israel Funds, Oxford Bioscience Partners, Pfizer Strategic Investments Group, Pitango Venture CapitalAll Jobs: at superDimension
| Web Site: | www.superdimension.com |
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| Headquarters: | 161 Cheshire Lane Suite 100 Minneapolis, 55541 United States |
| Industry: | Medical Devices and Equipment |
