Manager Regulatory Affairs (Companion Diagnostics)
Responsible for guiding Regulatory staff and participating in the development of submissions for product registrations, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams and negotiates with regulatory agencies to expedite approval of product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. Manages activities associated with regulatory approval of in vitro diagnostic medical devices.
- Identifies, interprets, and disseminates new regulatory trends, expectations and guidance documents. Responsible for assessment of device changes for regulatory implications.
- Develops positive and proactive approaches for regulatory activities to ensure customer satisfaction.
- Manages and prioritizes activities of Regulatory Affairs Specialists and/or other regulatory support roles as necessary.
- Represents the company during communications and meetings with health authorities and interfaces with regulatory authorities on regulatory and technical matters, as appropriate. Ensures compliance with regulations and laws pertaining to company business, provides guidance and advice.
- Leads the identification of regulatory risk areas and develops alternative courses of action. Assesses impact of new regulations and works with the Organization to implement appropriate changes.
- Leads others and provides guidance on interpretation and application of specified regulations. Independently reviews and approves Regulatory Strategy Documents.
- Regulatory Plans, Essential Requirements documents, procedures, SOPs and other documentation with respect to commitments, regulations and filings.
- For CDx or Lifecycle Support areas have primary 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.
- Educates others and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic region and discipline as relevant for assigned projects.
- Provides advice and counsel with respect to product labeling relative to compliance with applicable regulations. Reviews and approves product labeling to ensure conformance to global requirements. May also include compliance review of advertising materials to ensure product claims are appropriately presented in customer and public communications.
- Provides training to VMSI associates regarding GLP, GMP, GCP and other domestic and international regulations, standards and directives.
- Responsible for managing indirect and direct reports which includes, but is not limited to, hiring/firing decisions, selection, performance feedback, discipline, pay decisions, and handling employee’s grievances/complaints.
- Partner with Regulatory team members to identify areas for process improvement and alignment initiatives.
- May perform other duties as required or assigned.
- Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
- Other duties as assigned by management.
- B.S./B.A. in a science or related life science field; advanced degree preferred.
- 5 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred. Advanced degree counts toward years of experience.
- Experience with regulatory submissions for IDE, 510(k), PMA and CE Mark.
- Experience in diagnostics or biomarker development with emphasis on oncology a plus.
- Advanced scientific degree a plus.
- Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus.
- For CDx experience with submissions for: IND, NDA/BLA or pharma experience preferred.
- Experience in a supervisory or equivalent project leadership role preferred.
Ability to travel up to 25% of the time.
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Job posted: 2021-04-06