Irvine, California

Kelly is currently seeking a Sr. Regulatory Affairs Specialist for an on-going opportunity to work for one of the largest well known Global medical device companies in the world.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

JOB SUMMARY

Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.

 

DUTIES & RESPONSIBILITIES

Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations and company procedures and guidelines, responsible for the following Regulatory activities:

  • Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
  • Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
  • Author technical files and design dossiers for products to be distributed in the EU.
  • Prepare international documentation to support product registration internationally.
  • Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
  • Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal company policies and procedures.
  • Review and approve product modification documentation.
  • Communicate business related issues or opportunities to next management level.
  • Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Perform other duties assigned as needed.

 

EXPERIENCE AND EDUCATION

BS degree in Engineering, Physical or Biological science plus a minimum of 4 years experience in Regulatory Affairs or other related discipline in the medical device industry.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

  • Must be familiar with MS Office applications
  • Excellent communication skills (verbal and written)
  • Project management skills
  • Problem solving skills
  • Presentation skills
  • RAC Certification preferred

 

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

  • This position reports directly to Manager of Regulatory Affairs
  • This position is not responsible for directly managing personnel

 

EXTERNAL INTERACTIONS

  • This position will be required to communicate with international regulatory affiliates on a regular basis pertaining to product development and launch activities.
  • This position will be required to communicate with Regulatory agencies worldwide pertaining to review of product submissions and company-wide audits.


Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

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 (plus, did we mention we provide a ton of benefits?). 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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Irvine, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

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