Regulatory Affairs Specialist

Hemostasis; Saint Paul (MN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Job summary

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat and wound healing devices. The company seeks a Regulatory Affairs Specialist to ensure compliance with medical device regulations and to guide submissions with regulatory agencies.

This in-office role in Saint Paul requires a Master’s in Regulatory Affairs and Services, strong communication skills, and the ability to adapt to evolving requirements.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory strategy

Regulatory submissions

Communication skills

Education

Master's degree in Regulatory Affairs and Services

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.

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.

Qualifications

• 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

• 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.