Strong project management and cross-functional leadership skills
Effective negotiation and communication with internal stakeholders and external regulators/partners
Proficient in business software systems and electronic workflows relevant to the role
Strong working knowledge of:
EU IVDR (2017/746), FDA regulations (21 CFR 807, 809, 820/QMSR)
ISO 13485 and ISO 14971
CLIA Standards
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.
Benefits
Health insuranceDental insuranceVision insurance401(k)Flexible scheduleEquity / stock optionsParental leave
Additional Information
By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$49,700.00 - $81,650.00 The Advanced Regulatory Affairs Specialist independently manages regulatory activities for assigned product lines and contributes to regulatory strategy. This role operates with limited supervision and is responsible for ensuring compliant and efficient execution of regulatory deliverables across the product lifecycle.
Biotechne · Minneapolis, MN