Regulatory Affairs Specialist

Adecco is currently assisting one of our clients in Canoga Park looking for a Regulatory Affairs Specialist.  This is a long-term temp position.  If you feel you qualify please apply.

The Regulatory Affairs Specialist will be responsible for all aspects of the regulatory department.

Responsibilities:

  • Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
  • Represent Regulatory Affairs on assigned project teams.
  • Attends product development team meetings
  • Develops the regulatory strategy for project team(s).
  • Applies advanced regulatory expertise to the evaluation and solution of submission problems.
  • Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
  • Review and interpret scientific literature and summarize effectively in writing.
  • Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
  • Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
  • Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
  • Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing.

Requirements:

  • Bachelor's degree in Biology, Chemistry, bio-engineering or related scientific area or two years' experience in the device / diagnostic, biologic, and / or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products 2 years of IVD.
  • Must be well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies. Experience in the balance and application of regulatory requirements.
  • Direct and positive experience in communicating with Regulatory Authorities and Distributors. Regulatory review experience of promotional marketing materials, press releases, labeling, etc. Strong oral and written communication skills, as well as the ability to provide scientific presentations.
  • Ability to compile data and summarize results Hands-on, action-oriented, and able to implement effectively through his/her team.
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.

Adecco provides one of the most comprehensive benefits package in the industry to contract workers. Benefits are available to you as a contractor after one week of employment.

Click on Apply Now to be considered for this Regulatory Affairs Specialist position in Canoga Park.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

 

  • Apply with Adecco

Reference number US_EN_99_025142_413559