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Regulatory Affairs Consultant

Job Description

Title: Regulatory Consultant

Location: Monrovia, CA

Duration: 12 months

About the Company:

Join this class III medical device companies quality/regulatory team and be the expert on all matters regulatory. This person will be responsible for post market approvals, and 510k submissions. This person will ensure that all regulatory requirements are met both internationally, and domestically.

The Role:

There is one consulting position available supporting the quality/regulatory team, and reporting to the Director of Regulatory Affairs.

Responsibilities:

  • Effectively submits
  • Critical team leader, thought leader, regulatory SME, and strategist.
  • Plans, leads, tracks and executes global regulatory submissions strategies for global markets for new and sustaining product lines.
  • Plans, reviews, tracks, approves all forms of labelling, procedures, ad & promo, and all required forms of documentation applied to medical devices.
  • Represents the BG (Business Group) on internal Philips and on external regulatory related committees.
  • Works closely as key team member along with R&D, Quality, Regulatory, Medical, Marketing, and Clinical on all aspects of product life cycle.
  • Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments
  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

Qualifications:

  • At least 7 years of experience in regulatory affairs
  • Familiarity with international and domestic regulatory requirements
  • Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) desired.
  • Bachelor's degree in science or engineering required

Sthree US is acting as an Employment Business in relation to this vacancy.

Sthree US is acting as an Employment Business in relation to this vacancy.