Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry.  We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations.

Responsibilities Include:

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions.
  • Analyze validation test data to determine whether systems or processes have met validation criteria.
  • Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
  • Develop validation master plans, process flow diagrams, test cases, and standard operating procedures.
  • Create, populate and maintain the database for tracking validation activities, test results and validation systems.
  • Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Prepare additional information or responses as requested by regulatory agencies.
  • Research and interpret regulatory rules or rule changes and ensure they are communicated through company procedures.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Advise team members on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.


  • Master’s degree in Regulatory Affairs and Services.
  • Excellent written and oral communication skills.
  • Demonstrate proactive and strategic thinking and be able to handle change and ambiguity.

Competitive industry compensation based on experience

  • 401K, Dental, Life, Medical, Disability
  • Full-time in-office

Hemostasis, LLC believes in the synergy of teamwork while maintaining an entrepreneurial spirit, providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement and related benefits.

Jobsite: Saint Paul, MN

Apply to:

Apply to Personnel Department, Hemostasis LLC, 5000 Township Pkwy, Saint Paul, MN 55110