Liaison with International Regulators and In-country Regulatory Partners to develop and implement international country specific Regulatory strategies to achieve business objectives.
- Provide technical guidance and support for development of Regulatory submissions consistent with country-specific requirements in Intercontinental countries, APAC, LATAM.
- Collaborate with Regulatory Franchise Directors to Develop International Regulatory strategies for existing and new products registrations.
- Collaborate with International Sales and Marketing.
- Direct and coordinate resources related global submission activities.
- Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.
- Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation.
- Establish project priorities to meet business objectives.
- Support and maintain Quality initiatives in accordance with Quality Policy.
- Continuously assess ways to improve Quality.
- Advise team of prevailing and evolving global regulatory requirements and environment.
- Develop, implement, and maintain policies and procedures.
- Coordinate post-market approval activities.
- Foster employee career development.
- Participate in trade and professional organizations.
- Provide training to manufacturing and development teams on key global technical documentation / data requirements.
- Manage in order to ensure compliance with all relevant regulatory/legal requirements.
- Establish project priorities to meet business objectives, develop and report metrics.
- May perform other duties as assigned by supervisor.
- Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support.
- Ensure all employees are trained to do their work and their training is documented.
- Extensive background in the development of regulatory submissions and documentation.
- Excellent grasp of change control and test/validation requirements.
- Strong strategic, decision‑making, and risk assessment abilities.
- Highly developed written and oral communication, technical writing and editing skills.
- Excellent organizational, leadership, and interpersonal skills.
- Thorough knowledge of product development process and design control.
- Knowledge of EU MDD, CMDR, PMDA/PAL, APAC Country requirements, LATAM
- Bachelor’s degree.
- Advanced degree preferred.
- Professional regulatory certification(s) preferred.
- 10+ years Regulatory Affairs medical industry experience preferred.
- Demonstrated experience achieving regulatory approvals.