Medasense is looking for a Regulatory Affairs Manager
Medasense Biometrics is a medical device company that develops an innovative, proprietary platform technology for automated and continuous assessment of a patient’s pain level. Medasense is seeking to revolutionize the diagnosis of pain through its flagship product: A device that uses a unique combination of multiple non-invasive sensors and state of the art algorithms to monitor pain at any time and in any procedure.
Medasense is growing rapidly and looking Regulatory Affairs Manager, preferably with experience in the medical device industry, to join our dynamic and fast-paced environment.
Developing and implementing global regulatory strategy and road-maps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
- Together with professionals from other departments and in other countries, translate regulations and standards into product requirements
- Ensure product compliance to internal policies and external regulations and standards
- Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU, Canada and Asia [e.g. 510(k)/PMA, CE Marking, Health Canada, Korea, CFDA].
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Maintain regulatory files and tracking databases as required
- Communicate with regulatory agencies as needed
- Implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy;
Skills & Experience
- Bachelor/Master of Science degree in a software, technical, or biomedical discipline;
- 10+ years of experience in regulatory affairs, medical device regulated environment;
- Experience with successful preparation and submission of 510(k)\/PMA and international documents for registration and/or marketing of medical devices worldwide;
- Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations;
- Knowledge of FDA policies as well as familiarity with current FDA requirements and expectations
Experience in interacting with FDA and other regulatory agencies
- Experience in supporting international registrations (FDA) and clinical investigations (preference);
- Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations
- Knowledge of the CFDA requirements is preferred;
- Thorough knowledge of medical device product development and design control.
- Excellent verbal and written communication skills in English; Analytical / systematic / logical thinker;
If you meet all criteria Please send your CV to JobsClinical@nullmedasense.com