Director of Regulatory Affairs
elemed, San Diego, CA, United States
The Director of Regulatory Affairs will be based in San Diego, CA
The role includes but is not limited to the development and implementation of regulatory strategies for new product submissions, handling existing product registrations, including variations and renewals, interacting with global internal stakeholders as well as external consultants/service providers in support of registration activities, and developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements.
This role will also oversee the hiring, training, and career development of their direct reports
Key Accountabilities
Lead and mentor junior regulatory staff Lead existing registrations by preparing and filing variation and renewal applications for approvals or extensions of approvals in various countries around the world. Provide oversight and guidance to external service providers supporting registration activities. Work closely with cross-functional teams on submission strategy and documentation development for new product submissions Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of registration milestones. Assist in the maintenance of departmental systems used to track product registrations and compliance programs. Directly contact regulators on behalf of the organization during inspections and/or meetings. Perform additional tasks as required. Education
Bachelor’s degree in Science, Engineering, Business Administration or equivalent. Advanced degree (Master’s degree or higher) preferred. Experience
Minimum 10 years of relevant work experience, preferably within the Medical Device industry. Minimum 5 years of managing a regulatory team. Experience working with external service providers, consultants, and regulators required. Prior experience in Regulatory Affairs. International Regulatory knowledge (US, EU, etc.) Knowledge of medical devices and their regulation. Familiarity with software-controlled devices, SaMD, and Cybersecurity Ability to travel up to 10% domestically and internationally may be required. Strong project management skills and organizational abilities. Excellent written and verbal communication skills. Proficiency in Microsoft Office Suite, especially Excel and PowerPoint. Proven ability to handle multiple priorities simultaneously while meeting deadlines. Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies.
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Lead and mentor junior regulatory staff Lead existing registrations by preparing and filing variation and renewal applications for approvals or extensions of approvals in various countries around the world. Provide oversight and guidance to external service providers supporting registration activities. Work closely with cross-functional teams on submission strategy and documentation development for new product submissions Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of registration milestones. Assist in the maintenance of departmental systems used to track product registrations and compliance programs. Directly contact regulators on behalf of the organization during inspections and/or meetings. Perform additional tasks as required. Education
Bachelor’s degree in Science, Engineering, Business Administration or equivalent. Advanced degree (Master’s degree or higher) preferred. Experience
Minimum 10 years of relevant work experience, preferably within the Medical Device industry. Minimum 5 years of managing a regulatory team. Experience working with external service providers, consultants, and regulators required. Prior experience in Regulatory Affairs. International Regulatory knowledge (US, EU, etc.) Knowledge of medical devices and their regulation. Familiarity with software-controlled devices, SaMD, and Cybersecurity Ability to travel up to 10% domestically and internationally may be required. Strong project management skills and organizational abilities. Excellent written and verbal communication skills. Proficiency in Microsoft Office Suite, especially Excel and PowerPoint. Proven ability to handle multiple priorities simultaneously while meeting deadlines. Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies.
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