Sr. Regulatory Affairs Specialist Job in Saint Paul 55101, Minnesota US
Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Sr. Regulatory Affairs Specialist
Job Description:
Sr. Regulatory Affairs Specialist
Job Purpose:
The Regulatory Associate is responsible for activities which lead to, and maintain regulatory approval to market devices.Additionally, the Associate is responsible for assessment of device changes for regulatory implications.
Key Responsibilities:
Develop strategies for regulatory approval of medical devices.
Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes. (Some activities are CRM only)
Develop and deliver presentations to global regulatory agencies.Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization.Coordinate Boston Scientific comments on proposed regulations.
Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
Participate in training and mentoring of staff.
Coordinate IFU development activities (VI ES only).
Participate in department systems development initiatives.
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications:
6 - 9 Years with BA or 4 - 7 Years with MBA
The above statements are intended to describe the general nature and level of work being performed
by people assigned to this classification.They are not intended to be construed as an exhaustive list
of all responsibilities, duties and skills required of personnel so classified.
Please contact your local EHS department for more information on physical requirements.
Job Experience:
6 - 9 Years with BA or 4 - 7 Years with MBA
Minimum Education Required: Bachelor
Years of Experience Required: At Least 3 Years
Expected Travel Time: None