Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
Key Areas of Responsibility:
- Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada].
- Collaborate with worldwide colleagues regarding license, license renewals and updates
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Communicate application progress to internal stakeholders
- Maintain regulatory files and tracking databases as required
- Communicate with regulatory agencies as needed
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
- Bachelors/Master of Science degree in a software, technical, or biomedical discipline
- Minimum 6 plus years of experience in medical device regulated environment.
- Experience with successful preparation and submission of 510(k) or 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
- Experience in supporting international registrations (FDA) and clinical investigations (preference)
- Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference)
- Knowledge of the SFDA requirements. (preference)
- Excellent verbal and written communication skills (English)
- Enthusiastic, self-motivated regulatory professional
- Good communicator and team player who is able to work in a flexible and goal oriented environment
- Structured way of working
- Problem solving and time management skills