Kelly Services Regulatory Approval Database Analyst in Raynham, Massachusetts

Regulatory Approval Database Analyst

Raynham, MA

Kelly Services’ Outsourcing & Consulting Group has an opening for a Regulatory Approval Database Analyst (RAD Analyst) in Raynham, MA. This is a long-term assignment offering enhanced benefits. To be eligible for this role candidates must not have any employment restrictions regarding how long they can work for any employer in the US.

The RAD Analyst will enter product approval requests into the buyers Product Registration ‘Regulatory Approval Database’ (RAD) database to enable product release to World Wide Markets, while 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.

Job duties:

  • 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.

  • Performing special projects as required.

  • Assist RAD Investigator with approval investigations as required.

  • Perform other duties as assigned.

Qualifications:

  • 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.

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

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. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

Why Kelly ® ?

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.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm