Senior Regulatory Affairs Specialist

ProKatchers LLC; Chaska (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

ProKatchers LLC in Minnesota is seeking a Senior Regulatory Affairs Specialist to lead regulatory programs and ensure compliance through all product life-cycle stages. The role focuses on post-market activities, global submissions, and cross-functional collaboration with technical teams.

The professional will coordinate pre-market registrations, reporting, and corrective action processes, while supporting labeling and data analysis for compliant commercialization of medical devices.

Qualifications

• Bachelor’s degree in a relevant field with 5+ years of experience.
• Master’s degree with 3+ years of experience.
• Medical Technologist background and IVD experience strongly desired.

Responsibilities

• Plan, coordinate, facilitate, and report on regulatory programs.
• Evaluate, coordinate, prepare and implement post-market regulatory activities.
• Plan and implement pre-market registrations, reporting, and compliance per development plans.
• Implement global regulatory compliance programs for corrective actions and adverse event reporting.
• Prepare premarket submissions (510(k), PMA, Technical Dossiers) for US and other governments.
• Assist technical departments and suppliers with clinical data for regulatory notifications.
• Serve as team expert for materials review, experimental designs, data analysis, and labeling related to registration and commercialization.

Skills

Regulatory Affairs

Data Analysis

Global Regulatory Compliance

Education

Bachelor’s degree in field

Master’s degree in field

Job description

Job Title : Senior Regulatory Affairs Specialist

Duration : 12 + Months

Specific Skills :

Regulatory Affairs / Data Analysis / Global Regulatory Compliance

Skills :

• The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on the organization’s regulatory programs.
• The incumbent’s primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.
• Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
• Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
• Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
• Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Qualifications :

• Bachelor’s degree in field with 5+ years exp. OR Master’s degree in field with3+ years exp.

Medical Technologist background and IVD experience strongly desired