Bluejay Diagnostics is a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression. To help us with our mission, we are searching for a Manager, Regulatory Affairs. Under the direction of the CEO, and in collaboration with Product Development team, the applicant will support regulatory submissions and be the main interface between Bluejay and regulatory agencies. This position will collaborate effectively with internal departments and key outside vendors to ensure the commercial success.
• Lead development of regulatory strategy for all products.
• Maintain responsibility for development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions, 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed.
• Lead development of responses to regulatory authorities’ requests for additional information.
• Maintain responsibility for review and approval of product labeling (including IFU) and other ancillary labeling-related matters.
• Ensures key stakeholders are apprised of regulatory developments that may impact project goals, communicating in a professional and timely manner.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management.
• Maintains current knowledge of FDA and global regulations, provides strategic input for development plans and implements changes required for regulatory compliance.
• Partners with clinical operations team to ensure regulatory compliance.
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Maintain responsibility for maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.
• Manage outside regulatory counsel and contractors.
• Other ad hoc projects and requests
• Bachelor’s degree in an appropriate scientific or other related field
• 6-8 years’ experience in Medical Device Industry, including a minimum of 5 years’ experience in a Regulatory Affairs capacity.
• Regulatory affairs experience in writing US submissions is mandatory and experience in collaboration and working with the Regulatory Authorities directly is mandatory.
• Strong interpersonal, organizational, and time management skills.
• Knowledge of EU submission process and requirements (preferred)
• Ability to commute/relocate to our Acton, MA office.
• Medical, Dental and Vision insurance
• Paid time off
• Parental leave
• 401(k) plan with company match
• Flexible spending account
• Short and Long-term Disability
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.