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26 days old

Sr. Regulatory Affairs Specialist, Medical Device

Kelly Services
Irvine, CA 92604
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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-28 Expires: 2021-06-28

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Sr. Regulatory Affairs Specialist, Medical Device

Kelly Services
Irvine, CA 92604

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