Regulatory Affairs Medical Device Manager
vor 2 Wochen
**Summary**:
**About the Role**:
**Major accountabilities**:
- You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance.
- Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned projects/products, identifying the required documentation for timely global submissions to deadline.
- Proactively communicate RA MD regulatory strategies, risks and key issues throughout the life cycle, to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.
- Lead, prepare and communicate RA MD Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
- Establish and maintain a single point of contact with global HAs.
- Represent department on due diligence teams for in-licensing and divestment opportunities.
**Your Experience**:
- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology,Biology) or equivalent
- Medical device & Drug/Device Combination Products regulatory affairs experience, in the pharmaceutical and/or medical device industry.
- Good knowledge and experience in medical device & Drug/Device Combination Products regulatory submissions and approval processes, with understanding of product development life cycle.
- Ability to critically evaluate data from a variety of sources, work in interdisciplinary teams and prioritise activities, timelines and workload.
- Strong interpersonal skills and experience working in a complex, cross functional organization.
- Fluency in English.
**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
**Join our Novartis Network**:
Division
Development
Business Unit
Pharmaceuticals
Location
Austria
Site
Schaftenau
Company / Legal Entity
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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