Sr Regulatory Affairs Specialist

Location
Madison, WI
Posted
May 17, 2021
Required Education
Bachelors Degree
Position Type
Full time

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years.  We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research.

We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member.  We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections.  Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers.  

Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie.  Sustainability is important – we invest in energy efficiency and use renewable energy.  Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce.   Check out our campus through this map, and learn more about the our people and sustainable practices.

OUR TEAM: We are a small team of very motivated and energetic individuals. We are always seeking to drive speed to market by the least burdensome, but compliant path.  We work very closely together on new product development and realization projects and ensure that we support each other in our day-to-day roles and in our department.

YOUR ROLE: As part of our Regulatory Affairs team, you will be an important part of our new product development and realization teams from start to finish making sure all regulatory requirements are met.  You will work to communicate and ensure that our products comply with regulations and provide top-notch regulatory support.  You don't live in Madison area? This position can be virtual, onsite, or a combination of both!

YOUR EXPERIENCE: You will bring at least 2-4 years regulatory affairs experience including experience with in vitro diagnostics devices and will share your experiences with 510(k)s, pre-market approvals, and CE marking as well.  You are a self-starter with excellent communication skills and have a knack for detail.

To apply, view a complete job description, and learn more about our company, please click the "apply" button below. 

Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.