Senior Specialist, Regulatory Affairs and Quality – Nordson Corporation – Jobs in St. Petersburg, FL | OpenJobs AI

Job Details

Overview Company

Senior Specialist, Regulatory Affairs and Quality

Nordson Corporation

2 days ago

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OnsiteFull-timeSenior

Summary

Nordson Corporation is seeking a Senior Specialist, Regulatory Affairs and Quality to join their team in St. Petersburg, FL. The role involves supporting compliance activities within an FDA-regulated and ISO-certified medical device environment.

About the Role

As a Senior Specialist in Regulatory Affairs and Quality, you will be responsible for preparing and maintaining regulatory submissions, leading communication with regulatory bodies, and ensuring compliance with FDA and ISO requirements. You will also manage the Quality Management System, facilitate audits, and support post-market surveillance activities. Collaboration with cross-functional teams is essential to ensure compliance in product development and supplier management.

About You

Required:

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field.
5+ years of experience in medical device regulatory or quality roles.
Hands-on experience with FDA and ISO requirements.
Experience preparing regulatory submissions such as 510(k) and supporting CE marking documentation.
Strong understanding of CAPA processes and audit practices.
Excellent technical writing, documentation, and communication skills.

Preferred:

RAC (Regulatory Affairs Certification) or ASQ CQE/CQA certifications.
Experience with international regulatory pathways.
Experience supporting FDA inspections or ISO audits.

Benefits

Supportive culture in a growing and dynamic work environment.
Opportunities for skill development and career advancement.

Nordson Corporation

At Nordson, we believe that anything is possible. We empower our global team of employees to engineer, manufacture, and market innovative products and systems that are essential to everyday life. These differentiated products and systems are used for precision dispensing and processing and serve a variety of end markets, including packaging, transportation, medical, and electronics. Founded in 1954, we are guided by our values of integrity, respect for people, customer passion, energy, and excellence. We care for our employees and provide them with opportunities to advance their careers and make an impact, inside and outside of work. Nordson is headquartered in Westlake, Ohio, and has direct operations in more than 35 countries to support our products and systems with application expertise and a direct global sales and service organization.

St. Petersburg, FL