New Regulatory Affairs Professional 3 Job in Newark, DE!
Position Title: Regulatory Affairs Professional 3

Position Number: 328051

Location: Newark, DE 19702

Required Skill Set:

Design, Documentation, FDA, Manufacturing, Regulatory Affairs

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Regulatory Affairs Professional 3
Location: Newark, Delaware, 19702
Duration: 9 Months
Schedule: Shift (8am-4:30pm)

Description:
• Regulatory Affairs Specialist supports changes to commercial in vitro diagnostic reagents and consumables at Client Healthineers'' or prepare and submit product related regulatory submissions to international Regulatory Affairs team members.

Responsibilities Include:
• Assesses and documents regulatory impact of design and manufacturing process changes for commercial products.
• Communicates with Regional regulatory teams to determine global regulatory impact.
• Participates in Change Review Board representing Regulatory function.
• Reviews and approves project documentation and labeling.
• As needed, prepares/submits 510(k) s, 510(k) notes to file, PMA 30 Day notices, supplements and annual reports, and updates IVDD documentation.
• Maintains awareness of U.S. and global regulatory legislation and assesses impact to ongoing projects.
• Identifies, analyzes and implements country specific requirements necessary for product related submissions.
• Plans and prepares product related submissions with Client internal (e.g. Regional Units) or external organizations according to regulatory requirements.
• Performs regulatory projects or acts as a member of the project steering group.
• Submits required documentation/information to local authorities or Client internal.

Required Knowledge / Skills, Education and Experience:
• Bachelor''s degree in related discipline.
• Strong leadership, interpersonal, communication and organizational skills required.
• Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
• Must be able to set priorities as well as adapt to changing priorities.
• Demonstrates knowledge of organization''s business practices and issues.
• 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge; advanced degree May be substituted for some years of experience, where applicable.
• Experience with IVD industry and/or FDA submission experience.
• Knowledge and experience with global registrations a plus.
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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