Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs Specialist will support Software heavy devices as well as be a technical and cultural leader for the IVS Regulatory Affairs team and the Instruments RA department. You will need to understand, and be able to explain regulatory strategy for more complex devices as the product portfolios expand; and a person with a principal level knowledge and understanding is needed to support.

We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division. This is a Hybrid or Remote role with in office expectations, to be based in Portage, Michigan. Candidates that reside on the East Coast will be given preference.

What you will do  

• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products, intended for higher class medical devices which may include, but are not limited to IDEs, serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy).
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes, product claims/labeling.
• Determines requirements (local, regional, global) and options for regulatory submission, approval pathways, and compliance activities.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

What you need  

• Bachelor of Science, engineering or related Advanced degree
• A minimum of 9 years of working in an FDA regulated industry required.
• Previous experience authoring 510(k)s and other regulatory submissions required.
• Experience interacting with regulatory agencies required.
• Strong leadership skills.
• Demonstrated success in management of global regulatory strategy and submission activities required.
• Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).
• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
• Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
• Strong interpersonal, written and oral communication skills.
• Good time and project management skills with the ability to multi-task.

Preferred 

• MS in Regulatory Science
• RAC (Regulatory Affairs Certification)