• location: Cambridge, MA
  • type: Permanent
  • salary: $130,000 - $137,000 per year
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job description


Job Title: Regulatory Affairs Advisor - Medical Device

Position Responsibilities

  • Prepare regulatory assessments and plans for new products and design changes.
  • Prepare or direct the preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications. Participate in interactions with regulatory agencies needed to obtain product approval/clearance.
  • Support Investigational Device Exemption submissions.
  • Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews.
  • Review labeling, training, and promotional materials for compliance with claims and applicable regulations.
  • Assess product and manufacturing changes to determine regulatory impact.
  • Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on the clients products and regulatory procedures. Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements.
  • Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations.
  • Support US and international product registrations.
  • Support post-market regulatory compliance activities for US and international products.
Position Requirements

  • Education: BS or higher degree in engineering, science, health care or similar required.
  • Experience: 10+ years regulatory experience with at least 5 years regulatory experience in Medical Devices, including demonstrated experience in preparing successful FDA 510(k) submissions. Experience in preparing international submissions is a plus.
  • Experience in acting as a liaison to and communicating with regulatory agencies.
  • Strong working knowledge of FDA medical device regulatory requirements. Knowledge of MHLW, MDD, and other international regulations is a plus.
  • RAC certification is a plus.
  • Skills: Proficient in Microsoft Office.
  • Must possess strong oral and written communication skills
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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