Regulatory Affairs Advisor - Medical Device
Our Healthcare Optics Research Lab was established in 2013 and has collaborative research agreements with various hospitals to develop biomedical optical imaging and medical robotics technologies, with the ultimate goal of bringing medical devices to market. These devices will be used for a variety of applications, including Image Guided Therapy, Miniature Endoscopic Imaging, and Functional Imaging.
We are a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $29 billion in global revenue, its parent company ranks third overall in U.S. patents granted in 2016† and is one of Fortune Magazine's World's Most Admired Companies in 2016. We are committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. We are dedicated to the Kyosei philosophy of social and environmental responsibility.
† Based on weekly patent counts issued by United States Patent and Trademark Office.
All referenced product names, and other marks, are trademarks of their respective owners.
We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.
- 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 our 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.
- Proficient in Microsoft Office.
- Must possess strong oral and written communication skills.
Skills: Skills: FDA Submissions, 510(k), testing put into submission, document control, document review
For immediate consideration, please submit a recent resume in MS Word format in addition to a detailed cover letter with salary expectations.
- Job type: Direct hire
- Job function: Other
- Industry: Medical Devices
- Experience level: Associate
- Education level: Bachelor’s degree
- Location: Cambridge, MA
- Experience required:10 Years
- Relocation assistance: No; Only local candidates.
- Visa requirement: Only US citizens and Greencard holders