Job Description Summary
This position will beresponsible for all aspects of regulatory affairs including development and execution of global regulatory strategies and submissions formedical devices and drug/device combination products. The incumbent will perform essential duties andresponsibilities with minimal supervision while providing guidance to more junior regulatoryassociates.
- Manage customers' submission requirements to understand their Regulatory requirements in order to liaison with a cross functional team to address customer requirements
- Responsible for all B2B regulatory requests and submission
- Develop a regulatory process supporting the B2B Platform
- Represent the Regulatory Affairs function at the global cross functional business or product platform level.
- Analyze and interpret current or proposed domestic and international regulations for impact to BD products and processes to help ensure continuous compliance.
- Develop and execute global regulatory strategies by collaborating closely with cross-functional product development teams and regulatory associates around the world.
- Assess the impact of device modifications and develop robust non-filing justifications for US/EU regulated products.
- Coordinate and prepare premarket applications to the US FDA such as pre-submission meetings, 510(k)s, de Novo, IDE, or PMAs.
- Coordinate and prepare submissions to European Notified Bodies for timely approval of new products and product changes
- Provide support to regional regulatory associates for timely approval of BD products worldwide.
- Review and approve product labeling and promotional materials for compliance to global regulatory requirements.
- Participate in relevant trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts.
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry
- At least 5 years of experience with medical device regulations is required
- At least 2 years of experience with devices containing software or drug-device combination products is preferred.
- Human factors and usability engineeringexperience is preferred.
- Understanding of regulatory frameworks, and the ability to interpret and apply new or emerging regulations.
- Strong organizational and written/verbal communication
- Attention to detail
- Demonstrated problem solving abilities
- Self-motivated with the ability to effectively manage and prioritize multiple complex tasks.
Job ID R-18129