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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.

Responsibilities

  • 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.

Qualifications

  • 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 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.

Why Kelly ® ?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly ®

At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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