Regulatory Affairs Post-Market Intern

1w1 week ago

Werfen

Bedford, US · Internship · $44,000 – $60,000

About this role

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our OEM business, we research, develop, and manufacture customized assays and biomaterials.

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 based on business need. Ideal candidates combine technical and business knowledge with analytical strength and creative problem-solving abilities.

The Intern will be involved in day-to-day activities of the team, aiding other departments on projects. Gain in-depth knowledge of the product and its associated processes, particularly process activities directly involved. Assist in nearly all aspects of the workflow within an interactive and energetic workplace.

Assisting with regulatory decisions submissions for adverse events and authoring MDRs for FDA and Health Canada submission. Assist with correction and removal files and communications. Other assignments related to RA/QA support Werfen requirements and priorities, offering constant learning and daily challenges.

Requirements

Currently pursuing B.S. in Regulatory Affairs, Life Sciences, Engineering, Finance, Business, or Marketing with minimum of 2 college semesters complete
Ability to multitask
Confidence in using Microsoft Word and Excel tools
Enthusiasm, motivation, initiative
Ability to work within an interactive and energetic workplace
Technical and business knowledge
Analytical strength
Creative problem-solving abilities

Responsibilities

Perform entry level work of a routine nature requiring application of standard techniques, procedures and criteria
Aid team in day-to-day activities and other departments as they relate to department projects
Gain in-depth knowledge of the product and its associated processes
Assist with regulatory decisions submissions for adverse events and author MDRs for FDA and Health Canada submission
Assist with correction and removal files and communications
Review process procedures, change orders, equipment specifications, validation plans, and reports
Create, review and maintain department files
Summarize findings by computer readouts, statistical summaries, graphs and other methods

Benefits

Hourly range of $22/hr to $30/hr depending on relevant experience and grade level completed
Hands-on experience in regulatory affairs post-market activities
Opportunities to assist in nearly all aspects of the workflow
Equal Opportunity employer committed to a diverse workplace