Advanced Regulatory Affairs Specialist

Bio-Techne • Minneapolis, MN • 47min ago

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:

$62,300.00 - $102,350.00

POSITION SUMMARY

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.

Perform additional duties as assigned.

ESSENTIAL FUNCTIONS

Works in the regulatory affairs department on assigned projects.

Maintain regulatory files.

Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.

Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.

Review and approve documents, labels, and other documentation.

Assist with design control activities.

Assist 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.

Perform additional duties as assigned.

Education and Experience:

A Bachelor's degree with 2-4 years of relevant experience.

Or, a Master's degree with up to 3 years of relevant experience

Knowledge, Skills, and Abilities:

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-faced 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

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.

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services.

Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.

Similar Jobs

Marketing Specialist - B2C

Wondr Health • Saint Paul, MN • 30min ago

Sales & Marketing

JOB DESCRIPTION DEPARTMENT: Marketing POSITION: Marketing Specialist / B2C REPORTS TO: Director of Marketing SUPERVISES: NA JOB CLASS: Exempt PURPOSE : As a key member of the Marketing team, reporting to the Director of...

30min ago

Go to Apply

Senior Marketing Specialist

Bongards' Creameries • Chanhassen, MN • 32min ago

Sales & Marketing

Description Job Summary: Bongards' Creameries is seeking a highly-motivated Senior Marketing Specialist reporting to the VP of Marketing. The Senior Marketing Specialist serves as a member of the marketing team, leading...

32min ago

Go to Apply

Sr. Marketing Writer

Insight Global • Minneapolis, MN • 33min ago

Sales & Marketing

Job Description Insight Global is looking to hire a Sr. Marketing Writer to join one of our large software development clients. This is a fully remote role working Monday-Friday in either CST or EST timezones. In this po...

33min ago

Go to Apply

Administrative Assistant III

Boston Scientific • Maple Grove, MN • 37min ago

Management & Administrative

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in te...

37min ago

Go to Apply

Administrative Assistant - Receptionist

Minnesota State • Saint Paul, MN • 40min ago

Management & Administrative

All Job Postings will close at 12:01 a.m. CT on the specified Closing Date (if designated). Working Title: Administrative Assistant - Receptionist Institution: Metropolitan State University Classification Title: Office &...

40min ago

Go to Apply

Administrative Assistant

Toppan Merrill LLC • North Saint Paul, MN • 45min ago

Management & Administrative

Job Description: Toppan Merrill is a global technology leader committed to simplifying the complexity of regulatory disclosure and communications. We offer the most intuitive end-to-end SaaS platform for complex complian...

45min ago

Go to Apply

Accountant

Robert Half • Stillwater, MN • 51min ago

Finance, Accounting & Banking

Description We are looking for a dedicated Accountant to join a team in Stillwater, Minnesota. In this Contract to permanent role, you will collaborate with cross-functional teams to ensure accurate financial reporting a...

51min ago

Go to Apply

Accountant II

Donaldson Company, Inc. • Bloomington, MN • 53min ago

Finance, Accounting & Banking

Job Duties Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the fil...

53min ago

Go to Apply

Electrical Designer

Stanley Consultants Inc • Minneapolis, MN • 1h ago

IT & Engineering

Stanley Consultants is an award-winning and industry-leading global consulting engineering firm, with an unmatched commitment to culture, values, and ethics. We are dedicated to client experience and solve the most compl...

1h ago

Go to Apply

Principal Electrical Engineer

Stanley Consultants Inc • Minneapolis, MN • 1h ago

IT & Engineering

1h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.