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7 days old

Regulatory Affairs Project Manager

Kelly Services
Raynham, MA 02767
Kelly Services Outsourcing & Consulting Group has an urgent need for a Regulatory Affairs Project Manager in Raynham, MA. The Regulatory Affairs Project Manager will support the Regulatory Affairs Department in activities associated with preparing and submitting documentation to regulatory agencies specifically updating to the new EU Medical Device Regulations. Qualified candidates must have experience working on European submissions, working with cross-functional teams, experience leading teams and demonstrated knowledge of medical device regulations. This is a 100% on-site position and is open-ended/long-term and offers benefits.



**PRIMARY RESPONSIBILITIES:**




+ Set deadlines and monitor progress of project.

+ Prepare reports for upper management regarding status of project.

+ Assign responsibilities to others.

+ Maintain various tracking logs to ensure project stays on schedule.

+ Escalate delayed activity to Regulatory Affairs Management.

+ Work with cross-functional teams to gather required documentation.

+ Review documents from various sources for completeness.

+ Compile regulatory submissions.



**QUALIFICATIONS:**




+ Microsoft Outlook & Calendar Management, Excel Spreadsheets, Microsoft Word and PowerPoint Presentations able to create reports and manipulate data

+ Knowledge of Adaptiv software (preferred)

+ Understanding of compliance and regulatory requirements

+ Ability to work independently with limited supervision

+ Strong analytical skills

+ Flexibility able to adapt to compliance cycle activities and demanding timelines

+ Strong team player will need to collaborate with Regulatory Affairs team, and other functional team members (on conference calls & in-house meetings)

+ Excellent written and verbal communication, and the ability to communicate effectively with all levels of the organization

+ Strong decision making ability



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 shari.hulitt@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

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Posted: 2020-01-10 Expires: 2020-02-13

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Regulatory Affairs Project Manager

Kelly Services
Raynham, MA 02767

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