- 28-Nov-2016 to 30-Apr-2017 (CST)
- Edina, MN, USA
- Full Time
Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay
Be involved with a company that is changing the lives of people across the globe.
ARKRAY is currently looking to fill a Director, Scientific Affairs position responsible for being the science and technology knowledge leader for ARKRAY's US Laboratory product portfolio and understands the clinical application solutions and value propositions we market to our customers. Provides senior scientific leadership and technical direction for the US science team and US laboratory technician team at ARKRAY Factory USA (USF). Serves as primary liaison to the research, development and engineering teams of ARKRAY Japan for pre-market and post-market strategic technical product support, projects, and communications.
Duties and Responsibilities
- Primary science and technology leader for the United States Laboratory market product portfolio. Responsible for fundamental understanding of the science and technology within ARKRAY's laboratory and point-of-care marketed medical devices. Expertise in the area of urinalysis desired. Thorough understanding of the clinical applications of ARKRAY's IVD product portfolio and the value proposition we market to customers. Leads organization's efforts in resolving complex clinical application challenges within US customer base.
- Represents ARKRAY's product, science and technology portfolio at commercial tradeshows and industry meetings, supporting the US commercial teams in building market and customer awareness of ARKRAY's core science competencies and product solutions. Responsible for facilitating and developing relationships within the scientific community as it relates to urinalysis. Demonstrate in-depth knowledge in the area of urinalysis through educational efforts, review of key journals and attendance at key conferences. Maintain a reliable presence with scientific leaders to ensure they have a contact at ARKRAY.
- Provides senior science leadership direction to three primary processes:
- Pre-market: Coordination of US science team's support of pre-market activities including partnering with regulatory and research and development team members for conducting clinical trials, developing protocols for product performance studies and the development of product claims and 510k submissions support. Identifies, establishes and maintains collaborative relationships with key investigators and institutions to identify and address scientific needs and stays abreast of current scientific trends in urinalysis.
- Post-market: Provides work direction for US science team in support of customer support programs and clinical application and product performance inquiries from the customers and commercial sales and marketing teams. Coordinates science support for marketing initiatives. Provides science and technology insight into the post-market activities including field complaints and investigations, CAPA, product enhancements and customer communications.
- US Quality Control: Provide senior level science oversight to laboratory operations team that conducts quality control evaluations, product performance experiments and competitive product evaluations.
- Provides technical leadership into the processes of ongoing product improvement and enhancement activities, manufacturing transfers, process changes and validations, cooperating closely with ARKRAY's Operations, R&D, Quality Systems and Regulatory functions, as well as suppliers, customers and sub-contractors.
- Ensures that ARKRAY's internal training programs adequately prepare our commercial teams and technical customer service teams to deliver accurate information about ARKRAY's products and functionalities.
- Ensures design control compliance is followed for US led product development projects and overall compliance to ISO 13485 and FDA quality systems requirements.
Knowledge and Skills
- Minimum of 10 years' science and technology leadership experience in medical device industry or related field
- PhD in a physical or life science required (or MD with interest in commercial application of knowledge)
- Former lab director or equivalent experience is strongly preferred.
- Experience within IVD medical device industry, experience with pre-market clinical and analytical processes preferred
- Proven leadership and management skills, including ability to mentor and challenge staff of scientists and laboratory technicians
- Computer skills such as word processing, databases, spreadsheets, and excellent technical writing skills
ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities.