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Regulatory Affairs Intern

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Overview:

The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance. Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities.

Responsibilities

Position Description

Create Change Orders to update regulatory documentation and Standard Operating Procedures as needed.
Support the organization of regulatory files through IL’s electronic Regulatory Affairs Database.
Review labeling to comply with regulations and standards.
Compile documentation to support new regulatory filings to health authorities (including FDA 510(k) submissions and IVDR Technical Files in Europe).
Perform regulatory administrative tasks as needed.

Key Attributes

Ability to handle multiple priorities, projects and assignments simultaneously.
Strong analytical and interpersonal skills.
Strong proficiency using Microsoft Office (Excel, Word, PowerPoint).
Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
Other duties as assigned.

Additional Perks:

Werfen Team Sports: Tuesday Morning: Soccer, Thursday Morning: Hockey, Friday Afternoon: Flag Football
Werfen Gym Access: Members will have access to Werfem Gym and locker rooms with showers.
Subsidized Cafeteria prices: $2-4 Breakfast, $3-5 Lunch

Qualifications

Minimum Knowledge & Experience Required for the Position:

Currently pursuing B.S. in Biomedical Engineering with a minimum of 2 college semesters complete. Currently pursuing M.S. in Regulatory Affairs.
Ability to multitask.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.