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.
- 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.