Regulatory Intern
Parker
Hatfield, PA (In Person)
Full-Time
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Job Description
Position Summary The Regulatory Intern will support the Regulatory Specialist in a wide range of projects involved in the development and maintenance of medical devices and accessories both domestically and internationally. This role focuses on understanding and applying the laws, rules, and requirements surrounding device design and development, manufacturing, and quality assurance systems to improve process efficiency, implement regulatory controls, and develop compliant documentation Responsibilities Review standards and guidance documents to develop gap and impact assessments Review technical documentation, labeling, procedures, and records to improve compliance controls Develop procedures and resources to document and manage regulatory information and processes Contribute to evaluations and analyses for change management and trend reporting Contribute to international submissions and product change notification documentation Map processes and establish best practices to improve regulatory systems Assess and develop program initiatives for managing biocompatibility, risk management, economic operators, global management, and other regulatory framework activities. Qualifications Qualifications Currently enrolled in a bachelor's program in any scientific discipline or related field such as engineering Availability for a full-time co-op term May- August Familiarity with, Excel, PowerPoint, Microsoft Word, Visio Ability to work with cross-functional teams and other departments Skills & Competencies Problem-solving and root cause analysis mindset Strong reading and writing comprehension Strong attention to detail and commitment to documentation accuracy Comfortable working in a hands-on, fast-paced environment Clear written and verbal communication Ability to manage tasks independently and follow through on deliverables Equal Employment Opportunity Parker is an Equal Opportunity and Affirmative Action Employer. Parker is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job related reasons regardless of race, ethnicity, color, religion, sex, sexual orientation, age, national origin, disability, gender identity, genetic information, veteran status, or any other status protected by law. However, U.S. Citizenship, Permanent Residency or other appropriate status is required for certain positions, in accord with U.S. import & export regulations. ("Minority / Female / Disability / Veteran / VEVRAA Federal Contractor") If you would like more information about Equal Employment Opportunity as an applicant under the law, please go to Employees & Job Applicants | U.S. Equal Employment Opportunity Commission
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