Senior Regulatory Affairs Manager

Propeller Health   •  

Madison, WI

Industry: Healthcare

  •  

5 - 7 years

Posted 44 days ago

Why This Job is Important

Almost every part of our daily life is now digital, from hailing a cab to paying a bill. But our medicines have not caught up. They’re still stuck in an analog era. Propeller Health is changing that. Our mission is to improve people’s health by connecting the world’s medicines. Our growing team enjoys working together to create and apply technology to challenging problems that have enormous social costs.

We empower people to lead their lives without the limits of their chronic diseases.

Propeller’s aim is to make the disease experience different. How do we balance developing medical device products in a consumer facing world where technology changes constantly and users expect continual improvement? With an organization that has been dedicated to this balance from the very beginning. Our founders’ first hire was a person to build up a quality management system knowing that this is key to success in this market. The quality and regulatory team is an integral part of the product development process with support from the executive team and engineering alike to ensure that we make products that are safe, effective and relevant.

Essential Functions:

You help departments and employees find new ways to accomplish the goals of continually improving our health software and hardware for patients, while maintaining compliance with a large variety of regulatory requirements from different markets and customers. You smile as you work withinternal and external stakeholders to accomplish a common goal. You enjoy working on complex problems and navigating subjective and often unclear regulations and guidances.

Key Responsibilities:

  • Manage the research and preparation of regulatory projects targeted for EU and other international markets
  • Assist partners in the diligence process for new projects
  • Work with cross-functional teams to provide regulatory guidance through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements
  • Assist in the preparation of international regulatory submissions for the Propeller system. Subtasks include the management and updating of device technical files.
  • Own the transition process from MDD to MDR
  • Maintain records of regulatory submissions, correspondence with legal/regulatory bodies, and other partners

Other Requirements:

  • Expertise working with regulatory bodies regarding approvals, submissions, etc
  • Experience with international regulations for Europe, Asia and the Americas
  • Experience in Regulatory Compliance, specific to Quality systems, problem reporting, marketing, etc.

Qualifications/Min Requirements:

  • Bachelor’s Degree in a related discipline
  • 5-10 years of regulatory experience
  • Additional Desired Certifications:
    • RAC (Regulatory Affairs Certification) or other equivalent certifications

Key characteristics:

  • Driven by detail
  • Persistent
  • Task-oriented
  • Strong written and verbal communication skills
  • Ability to communicate regulatory requirements to key stakeholders

What we are not looking for:

  • A manager/director ⇒ We need a roll up the sleeves person
  • Analysis paralysis ⇒ Need to make decisions with what information we have or know how to get help
  • Inflexibility in thinking ⇒ Creativity in this space is a must