Regulatory Affairs Specialist

Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing. We are a worldwide leader in porcine and bovine animal genetics, partneringwith farmers to transform how we nourish the world – a mission that is important to a sustainable future. 

Our vision is clear: Pioneering animal genetic improvement to help nourish the world.

Genus PLC has an exciting opportunity. We are looking for a Regulatory Affairs Specialist to lead regulatory compliance of Genus products and technology in a fast-moving environment. The position is located in our Deforest office and hybrid work is an option. The Regulatory Affairs Specialist will define and drive global regulatory strategies for engineering solutions to support genetic improvement across Genus. As part of our Global Regulatory Affairs team, you’ll be at the forefront of our business and building solutions that ultimately provide genetic improvement to help nourish the world. 

• Develop, propose, and implement regulatory strategy for Genus biomanufacturing systems. 
• Work with Biosystems Engineering team to ensure compliance to design and development processes and procedures as well as methods and tools for product quality and regulatory compliance. 
• Act as the Regulatory liaison with global regulatory authorities on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activities. 
• Maintain regulatory conformity, certifications, and approvals for equipment or systems developed or supplied by Genus. 
• Prepare new global submissions for new product market and ensure changes to current products are appropriately reported and submitted to global regulatory authorities. 
• Plans coordinates and compiles regulatory submissions with minimal review and with sign-off responsibility.  

• Support inspections by FDA, certification body, and other regulatory agencies. 
• Uphold the Genus core values, mission and vision. 
• Position may require work responsibilities outside of normal business hours. 
• Performs other projects and responsibilities as assigned. 

Basic Qualifications: (required)

• Bachelor’s degree within Engineering or Science
• A minimum of 3 years of Regulatory Affairs working experience with laboratory equipment or similar products
• Familiarity with EMC/EMI testing, product safety testing, laser safety testing and related regulations, standards, and guidance documents (e.g., IEC 61326, IEC 61010, FCC Parts 15, IEC 60825, FDA/CDRH 21 CFR 1002.1).
• Experience in interfacing with applicable external test houses, certification bodies and/or other regulatory agencies
• Solid understanding of product development, manufacturing, quality assurance and/or Regulatory Affairs for laboratory equipment
• Experience in supporting R&D in implementing requirements and addressing findings from after such tests
• Good technical writing skill and communication skill in team settings.
• Proficiency on programs within Microsoft Office
• Ability to travel when required, approximately 10% of time
• Authorized to work in the U.S. without sponsorship

Preferred Qualifications:

• 5+ years of Regulatory Affairs working experience with laboratory equipment or similar products
• Laser product regulatory experience.
• Strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization in global markets.
• Certification

Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.