Regulatory Affairs Specialist

We have a full time remote Regulatory Affairs Specialist position available supporting our international regulatory product submissions.  We hold every member of our team to a high standard of excellence – because everyone on our team makes an impact on our success and contributes to our ability to thrive in the rapidly changing environment.

In this position, you would be responsible for ensuring the company is meeting all the federal and international regulations that apply to Microbiologics products, including writing, coordinating, and executing regulatory submissions in all applicable countries.  Microbiologics has global distribution to over 140 countries making this a challenging and rewarding position.  This position will be remote but would have occasional onsite requirements in our St. Cloud, Minnesota Headquarters including the initial onboarding and training. 

In this role, your key responsibilities would include:

• Authoring, coordinating, preparing, and/or reviewing regulatory submissions in multiple countries including but not limited to the US, UK, EU, Canada, Brazil, Saudi Arabia, Malaysia, Singapore, Mexico, United Arab Emirates, China, Pakistan, Indonesia, Australia, and many others.
• Ensuring that technical documentation and the EU declaration of conformity are drawn up and kept up to date.
• Ensuring post-market surveillance obligations are met.
• Medical device reporting obligations in all applicable countries such as reportable events, serious incidents and any other reporting required or requested from various regulatory agencies.
• Managing 510(k) submissions.
• Interpreting regulatory rules and rule changes and ensure they are communicated throughout the organization.
• Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
• Advising project teams on premarket regulatory requirements, export, and labeling requirements.
• Monitoring compliance activities of competitors.
• Managing recalls, FSCA and FSN in all applicable countries.
• Device registration, listing, licensing, and shipping restrictions for all regulatory jurisdictions where Microbiologics' products are marketed
• Reviewing and approving marketing materials.
• Reviewing and approving labeling including product inserts.
• Providing training and guidance as needed throughout the organization.
• Assisting distributors with documentation requests related to various regulations they may need to navigate.

Who is Microbiologics?

Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the world’s leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.

Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that "great vision without great people is irrelevant." That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.

We can we offer you?

Glad you asked!

We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few.  In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth. 

What makes you a good fit?

Our goal is finding the right individual for our team – we firmly believe that the right person is someone to invest in and invite to join our family. 

Here is what we are looking for:

• Bachelor’s degree preferably in a scientific, engineering, or regulatory field.
• 3 years previous experience in medical device/IVD regulatory affairs required.
• Submission experience required.
• Regulatory experience with the European Union and the United States is required.
• Regulatory experience with other countries is preferred.
• RAPS certification preferred.
• The ability to pass a background check and drug screening.
• Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required upon hire.