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.

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.

Position Summary

The Regulatory Affairs Manager at R&D Systems will lead a team of Regulatory professionals, working closely with the Sr. Director, Regulatory Affairs and the R&D Systems (RDS) Quality Assurance team to ensure compliance as we bring innovative products to a world-wide market. This is an on-site position with limited remote work upon approval.

Duties And Responsibilities

External Stakeholders

Facilitate meetings as needed with Regulatory Authorities and Notified Bodies to establish agreed upon regulatory requirements for new IVD products
Serve as primary Regulatory representative for R&D Systems to support work with OEM partners; working to implement new agreements and maintain/support OEM partners as defined in terms of agreement.
Serve as primary contact for Bio-Techne’s designated IVDR Notified Body (BSI); working to achieve and maintain CE certification of hematology products as identified by Business Partners

Internal Stakeholders

Lead the high-functioning, service-oriented Regulatory Affairs team at the R&D Systems site in Minneapolis, MN. Work with each team member to establish performance goals and support their professional development through coaching, training, etc.
Work with Regulatory leadership and Business Partners to allocate resources in alignment with business objectives. Establish and maintain a regular cadence of communication to monitor new developments and adjust accordingly
Provide inputs into project planning both cross-functionally and within Regulatory. Ensure regulatory requirements are considered as project inputs and monitored throughout. This is primarily achieved through project team membership.
Partner with Quality Assurance team to provide general regulatory guidance and support as necessary.

Regulatory Compliance

Author, file, and maintain regulatory submissions for In Vitro Diagnostic devices in various jurisdictions.
Author, file, and maintain regulatory DMF submissions for GMP grade products as identified by Business Partners
Coordinate with distributor partners to support product registration efforts; including but not limited to Australia, Brazil, Canada, China, European Union, Japan, Korea, and the United Kingdom.
Monitor global regulatory changes and report impact to Quality and Regulatory leaders during annual Quality Management Review meetings and Quarterly Business Review
Manage processes involved with maintaining global licenses and registrations for R&D Systems; provide similar support to partners.
Ensure compliance with product post-market approval requirements
Manage Adverse Event and Post-Market Vigilance activities with support from QA team and external partners

Education And Experience

B.S or higher degree in Biology related disciplines which provides for the background necessary to perform the work

Minimum 8 years of experience in an IVD manufacturing environment including ~4 years of Regulatory focused work

Demonstrated working knowledge of FDA and IVDR requirements.

Knowledge And Skills

Excellent attention to detail and organizational skills are required
Demonstrated success leading and working on a cross-functional team
Working knowledge of Microsoft Word and Excel are required
Data analysis skills are highly desirable
Results-driven with demonstrated ability to find solutions and achieve company goals in an effective, efficient manner
Able to flourish in a fast-paced, multi-tasking dynamic environment
Able to build strong relationships across a wide spectrum of internal and external parties
Ability to prioritize personal work to meet deadlines and complete multiple tasks accurately and efficiently in a fast-paced environment
Excellent verbal and written communication skills
Demonstrate knowledge of product lines

Why Join Bio-Techne

We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
We help our employees develop their careers through mentorship, promotional opportunities, training and development, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

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.

Bio-Techne is an E-Verify Employer in the United States.

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