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Job Details

Regulatory Affairs Specialist - Military veterans preferred

Company name
Kelly Services, Inc.

Location
Somerville, NJ

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Profile

Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a contract opportunity for a Regulatory Affairs Specialist with our client, a leader in the Pharmaceutical/Medical Device industry, located in Somerville, NJ. Please send your resume to Alicia Cali at alic019@kellyservices.com or call at 216.256.7768.\r
Requirments:\r
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\tDevelop regulatory deliverable timeline and schedule for assigned project.\r
\tReview and approve Change Projects, Change Orders, and project documentation.\r
\tComplete Preliminary and Final Regulatory Assessments and regulatory strategies.\r
\tParticipate in design control activities.\r
\tProvide support to backroom for BSI Technical File audits and FDA audits\r
\tPrepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications.\r
\tPrepare 510(k)\u2019s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy.\r
\tSubmit notifications to\u00a0Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.\r
\tProvide necessary documentation to country affiliates, where needed.\r
\tDaily communication and meeting attendance with project teams.\r
\tDaily or weekly communication with \u00a0Regulatory Management on project status and deliverables.\r
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JOB REQUIREMENTS:\r
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\tMust have a BS degree\r
\tMust have at least 4-5 years of experience in the medical device or related industry\r
\tMust have at least 3-5 year of Regulatory Affairs experience.\r
\tMust be able to work independently, utilizing research and problem solving skills, and the willingness to learn new skills.\r
\tMust have excellent written, verbal communication and presentation skills.\r
\tMust be able to communicate clearly, succinctly and effectively.\r
\tMust have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.\r
\tMust be able to work in a timeline-driven environment.\r
\tMust have previous experience with document management systems and change control systems.\r
\tProject team experience is a plus\r
\tExperience to manage a complex project is a plus\r
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This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.\r
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Why Kelly?\r
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As a Kelly Services employee, you will have access to numerous perks, including:\r
Exposure to a variety of career opportunities as a result of our expansive network of client companies\r
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Career guides, information and tools to help you successfully position yourself throughout every stage of your career\r
Access to more than 3,000 online training courses through our Kelly Learning Center\r
Weekly pay and service bonus plans\r
Group-rate insurance options available immediately upon hire*\r
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Apply Today!\r
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Why Kelly\u00ae?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG\u00ae) is one focus within the full array of Kelly Services\u00ae 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\u00ae

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.]]

Company info

Kelly Services, Inc.
Website : http://www.kellyservices.com

Company Profile
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.

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