Kelly Services Regulatory Affairs Specialist in Raynham, Massachusetts
Kelly Outsourcing & Consulting Group is seeking candidates for a Regulatory Affairs Specialist in Raynham, MA. This is a long-term salaried opportunity with a comprehensive benefit package.
The Regulatory Affairs Specialist will execute regulatory activities to support currently-marketed devices in the client’s sports medicine line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.
Support project teams by defining regulatory requirements to achieve compliance.
Work with project team to identify and address critical path or road block issues.
Create robust global regulatory strategies.
Ensure changes are effectively communicated to global partners for registration impact.
Ensure project plans and deliverables are compliant with appropriate design control procedures and other global regulation requirements as applicable.
Compiles regulatory submissions, filing amendments and correspondence with US and EU regulatory authorities.
Support International team with product re-registration.
Communicate effectively with Management.
Participates in process improvement and corporate initiatives as appropriate.
Support various audits as related to projects.
Maintains knowledge of current applicable regulations and guidance documents.
Maintains the highest levels of professionalism, ethics and compliance at all times.
A minimum BA/BS Degree with at least 4 years of regulated medical device industry experience (or related) is required
Knowledge of orthopedic implants a plus
Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part.
Familiarity with electronic submission preparation a plus
Excellent written and oral communication skills
Ability to handle multiple tasks and be detail oriented
This position comes with enhanced benefits which include:
50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
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.
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About Kelly ®
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