Kelly Services' Outsourcing & Consulting Group has an urgent need for a Regulatory Affairs Data Analyst in Raynham, MA. The Regulatory Affairs Data Analyst will enter product approval requests into the ‘Regulatory Approval Database' (RAD) database to enable product release to World Wide Markets, whilst maintaining complete regulatory compliance.
RAD Analysts receive RAD Processing Packages from RAD Investigators and execute the entry and validation of approval data into the RAD system. RAD Analysts also act as a secondary review of the approvals.
- Update request tracking processes to ensure workload and status is documented.
- Enters, maintains and validates regulatory approvals in the RAD system.
- Provides secondary review of approval requirements during data validation.
- Perform special projects as required.
- Assist RAD Investigator with approval investigations as required.
- Perform other duties as assigned.
- A Bachelors degree is required.
- A minimum of 2+ years of regulated industry experience is required.
- Basic working knowledge of FDA and/or European regulatory requirements is required.
- Experience with 510k's, Technical Files, PMA's and design dossiers is preferred.
- Experience with US and EU regulatory requirements is preferred.
- International experience outside of the US and EU is an asset.
- The ability to develop and maintain excellent working relationships with regulatory personnel is required.
- Ability to write, proofread and check documents for accuracy; ability to relate information to requirements; and ability to identify inconsistencies will be needed.
- Proficiency in the use of technology including MS Office Software Packages and Internet for word processing, spreadsheet analysis, database analysis, Internet research, etc. will be required.
- Excellent communication, organizational and problem-solving skills are required.
- Must be able to work successfully within a team environment and as an individual contributor.
This position comes with enhanced benefits which include:
- 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
- Paid holidays
- Paid sick days and vacation days*
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Online application system
- Never an applicant fee
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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