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.

Position Summary: 

The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings and support regulatory activities. This position will demonstrate advanced knowledge of regulatory changes and assist with communication to customers and regulatory authorities. In this position, you will work closely with internal colleagues and external partners to bring innovative products to market and support our business goals. 

Key Responsibilities: 

Strong communication skills with the ability to collaborate cross-functionally and with global external partners 

Ability to facilitate and guide regulatory and cross-functional team meetings. 

Seek development opportunities to strengthen your subject matter expertise. 

Manage coordination, preparation, and timely submission of regulatory documents and filings.  

Compile and update regulatory filings with little input. 

Identify changes impacting regulatory submissions. 

Research the history of a product and advise on global regulatory strategy.  

Assist with regulatory responses and interactions required by regulatory authorities. 

Communicate clearly and effectively with global regulatory authorities.  

Provide input into regulatory functions and processes.  

Propose and implement process improvements.  

Collaborates on projects of moderate complexity. 

Execute processes involved with maintaining annual licenses, registrations and listings.  

Support customer inquiries for regulatory support. 

Mentor, guide, and train internal partners to increase regulatory affairs awareness. 

Strong understanding of regulatory body of knowledge and processes. 

Consistently demonstrate knowledge of regulatory requirements in daily work. 

Provide strategic regulatory input to support business initiatives.  

Support the monitoring and interpreting of global regulatory requirements and international standards.  

Perform gap assessments and implement required process changes to maintain QMS compliance.  

Analyze and interpret changes to the global regulatory landscape. 

Ensure compliance with product post-market surveillance and vigilance requirements. 

Review and approve change controls related to proposed product/process changes and assessing their impact on specific regulatory requirements.  

Support the review and approval of product labeling, promotional, and advertising materials as needed. 

Education and Experience: 

Bachelor's degree with 3-5 years of relevant experience in regulatory affairs in an IVD manufacturing environment; Or, a master’s degree with up to 2 years of relevant experience 

 

Knowledge, Skills, and Abilities: 

Excellent attention to detail and organizational skills are required. 

Demonstrated success working on a cross-functional team. 

Working knowledge of Microsoft Word and Excel are required. 

Computer entry, typing, or electronic document filing skills are required. 

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. 

Must have excellent verbal and written communication skills. 

Introductory knowledge of molecular genetics and commonly technologies (e.g., PCR, Capillary Electrophoresis, Genetic Analyzers) 

 

 

 

Why Join Bio-Techne:

We offer competitive wages along with extensive benefits for employees and their families.We invest in our employees’ financial futures through retirement programs 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 an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that 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.

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

Bio-Techne is an Equal Opportunity Employer. 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.