Manager Regulatory Affairs, in Vitro Diagnostics
2 months ago
**Company Description**
The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx global submissions under limited management supervision. Develops and manages content strategy for regulatory submissions including technical files for CE marking, US PMAs, US IDEs, US 510(k), DE NOVO 510(k) and other relevant submissions. Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas, Precision Medicine, Medical Affairs and Commercial organizations. Represents CDx Device RA on teams to negotiate, influence and provide strategic advice to internal and external stakeholders.
**Responsibilities**:
- Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
- Seeks expert advice and technical support as required for strategies and submissions.
- Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.
- Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
- Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
This role can be based remotely anywhere within the U.S.
**Qualifications**
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems
- Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- Note: Higher education may compensate for years of experience
**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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