Regulatory Affairs Specialist Jobs

Hemostasis Corp

Location:
United States, Saint Paul

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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.

Job Responsibility:

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

Requirements:

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

What we offer:

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Additional Information:

Job Posted:
December 09, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Regulatory Affairs Specialist