Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.
- Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
- Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- For CDx or Lifecycle Support areas have responsibility for creation and submissions of US FDA pre-submissions, 510(k)s and PMAs for assigned projects.
- For International area ensures overall compliance with international standards and directives. Responsible for activities which lead to and maintain international regulatory approval to market devices.
- May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
- Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- Provides regulatory support on project teams.
- Serves as Functional Lead on project team(s).
- May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues.
- May perform other duties as required or assigned.
- B.S./B.A. in a science, engineering, or related technical field required (Advanced degree preferred)
- Regulatory Affairs Certification preferred.
- 5 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries required.
- Experience with Microsoft based applications and general knowledge of PC functions required.
- IVD device experience is preferred.
- Regulatory Affairs experience preferred.
- Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
- For CDx experience with submissions for: IND, NDA/BLA or pharma experience preferred.
- CDx specific experience in diagnostics or biomarker development with emphasis on oncology a plus.
- Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus.
Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs