Advanced Regulatory Affairs Specialist

Overview

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 provides tools for researchers to further treat and prevent disease worldwide.

Pay Range: $62,300.00 - $

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assures compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assists in creation and maintenance of regulatory files. Performs additional duties as assigned.

• Works in the regulatory affairs department on assigned projects.
• Maintains regulatory files.
• Coordinates with product development and/or R&D teams to request, develop, and prepare required data and reports for regulatory bodies and agencies.
• Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
• Reviews and approves documents, labels, and other documentation.
• Assists with design control activities.
• Assists in Risk Management activities.
• Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene, and Exposure Control manuals in accordance with the job.
• Performs additional duties as assigned.

• A Bachelor’s degree with 2-4 years of relevant experience.
• Or a Master’s degree with up to 3 years of relevant experience.

• Attention to detail and organizational skills are required.
• Working knowledge of Microsoft Word and Excel are required.
• Computer entry, typing, or electronic document filing skills are required.
• Must be able to work in a fast-paced environment where multitasking is required.
• Must have excellent verbal and written communication skills.
• Knowledge of technical, regulatory, quality and production management systems.
• Knowledge of documentation principles and processes.
• Skills in accuracy, clarity and proofreading.
• Skills in problem solving, identifying root cause and appropriately evaluating a course of actions.
• Knowledge of global regulations associated with in-vitro diagnostics.
• Technical document writing skills.

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and d.
• 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 to 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.