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Job ID
380917BR
Aug 11, 2023
Austria
Job Description
Associate Director Regulatory Devices (d/f/m), Kundl, Austria; Holzkirchen, Germany; or Cambridge, UK
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Medical devices play a central role in our ability to provide accessible medicines that are safe and easy to use – this is underlined by the fact that over ¾ of our approved biosimilars have associated devices in addition to a large portion of our approved generics – with numbers in development ever increasing.
The ideal candidate for this role brings exceptional device regulatory experience (8+ years), can work cross functionally and lead others in planning and delivering device relevant regulatory and technical documents across a diverse product portfolio. The candidate can independently manage leadership level stakeholders (both internal and external) to drive successful delivery of dossiers globally. Overall, the ideal candidate has the experience and capability to independently plan, coordinate, develop, and deliver high quality regulatory and technical documents for successful registration of both stand-alone and combination product type medical devices.
Your key responsibilities:
Your responsibilities include, but are not limited to:
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
Medical devices play a central role in our ability to provide accessible medicines that are safe and easy to use – this is underlined by the fact that over ¾ of our approved biosimilars have associated devices in addition to a large portion of our approved generics – with numbers in development ever increasing.
The ideal candidate for this role brings exceptional device regulatory experience (8+ years), can work cross functionally and lead others in planning and delivering device relevant regulatory and technical documents across a diverse product portfolio. The candidate can independently manage leadership level stakeholders (both internal and external) to drive successful delivery of dossiers globally. Overall, the ideal candidate has the experience and capability to independently plan, coordinate, develop, and deliver high quality regulatory and technical documents for successful registration of both stand-alone and combination product type medical devices.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Strategic regulatory oversight over a diverse portfolio of device / combination product programs – able to work operationally as well as lead others in planning and delivering high quality regulatory and technical documents according to program timelines.
- Cross functional engagement to clarify strategy and deliverables linked with defined device / combination product regulatory requirements and project timelines – communication of risks / opportunities to leadership level stakeholders.
- Ability to lead cross-functional operational strategy workstreams to improve processes and efficiency - communication of risks / opportunities to leadership level stakeholders
- Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of Notified Body Opinion interactions
- Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone devices.
- Supports audit readiness activities and medical device inspections including obtainment and maintenance of certification for stand-alone devices
- Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
- Support the generation and maintenance of design history files and review these documents during development and post-marketing, respectively
- Support of regulatory intelligence (legislation and trend review) and contributions to continuous improvement of submission process, templates and knowledge transfer within project teams
- Collaboration with external vendors and assurance of appropriate quality and timely delivery of relevant documents, files and certificates.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
What you’ll bring to the role:
Essential:
Desirable requirements:
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For Austria, this position the minimum salary is € 73,112.90/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Essential:
- Advanced University degree or equivalent education/degree in life science/healthcare is required (minimum requirement Masters degree or equivalent)
- 8+ year industry experience working in medical device development or registration with a solid grasp of relevant regulations and standards including MDR 2017/745, 21 CFR 820 / 21 CFR 4, ISO 13485 and ISO 11608
- Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions
- Experience in the generation of the technical file for stand alone device submission and experience in the generation of Notified Body Opinions or relevant CTD modules for combination products including module 3 sections P2.4, P3.5 and P7
- Fluent in English (oral and written) – with excellent verbal and written communication skills
- Attention to detail and quality focused
- Highly collaborative team player with ability coordinate deliverables cross-functionally
Desirable requirements:
- Experience leading teams and topics and within area of expertise in a matrix environment
- High change agility – ability to adapt quickly & effectively in a dynamic environment.
- Proactively / independently engages with internal and external stakeholders.
- Can clearly communicate complex topics to other experts / stakeholders
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For Austria, this position the minimum salary is € 73,112.90/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Division
SANDOZ
Business Unit
Sandoz Global Development
Location
Austria
Site
Kundl
Company / Legal Entity
Sandoz GmbH
Alternative Location 1
Germany
Alternative Location 2
United Kingdom
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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