- Position focus is on the development and post-approval of medical devices and combination products in sequence with drug delivery.
- Contribute to the development and implementation of CMC device regulatory strategy; Identify and assess regulatory risks
- Serve as the regulatory representative on project teams, making key project related decisions for post-marketing and/or development programs
- Serve as liaison to internal operations groups, development personnel and manufacturing partners
- Serve as regulatory contact with relevant regulatory authorities, and coordinating device CMC aspects of regulatory submissions
- Manage the regulatory submission process through to approval, including management and coordination of the preparation of regulatory documentation
- Provide critical review of regulatory submissions to ensure accuracy, adequacy, consistency and conformance to regulatory requirements and proper language
Additionally, the candidate should have:
- Regulatory experience for medical devices and combination products
- Familiarity with Medical Device regulations, Good Manufacturing practices and a record of successful submission strategies for combination products
- BA/BS/University degree required, Life/Health Sciences preferred.
- Demonstrate excellent communication and influencing skills internally and externally
- Demonstrate effective cross-functional and cross cultural skills, strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
- Ability to apply analytical and creative thinking problem solving
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Demonstrate strong organizational skills, including the ability to prioritize workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.