The Senior Manager/Director of Regulatory Affairs will play a critical role in the development of aesthetics injectable products through balanced compliance and managing of aspects of regulatory activities necessary to maintain and grow our business.
Participate in activities to ensure compliance with regional regulatory requirements.
Provide regulatory support for new product registrations, labeling compliance, regulatory document preparation per various international specific country registration.
Develop and manage procedures and systems to perform regulatory operational activities.
Develop and implement regulatory strategies for launching new products and maintaining existing products.
Keep abreast of new Regulatory changes in all target markets globally and new regulations and guidelines and ensure adherence throughout the product life cycle.
Work closely with contractors, distributors and registration agencies to register products for global sales.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely, accurate and efficient manner.
Provide input on regional regulatory requirements and standards to ensure that requirements are incorporated in product development.
Review and approve product labeling and promotional materials to ensure regulatory compliance.
Demonstrated capabilities to be agile and nimble in a start-up organization.
Effective communication and a reputation for integrity and ethical behavior are critical.
Strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.
5+ years of aesthetics injectables experience
5+ years of Regulatory Class III/PMA Medical Device experience.
Bias towards start-up experience in a fast-paced environment!
Strong analytical, problem-solving mindset.
Exceptional organizational skills and detail-oriented.
Strong written and verbal communicator with key decision-makers.