346519BR
Jun 03, 2022
Germany

Job Description

8! This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provide increased access to life-saving medicines to patients worldwide while further biosimilars are under development.

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 6 of our 8 approved biosimilars have associated devices.

The Regulatory Affairs Device Manager (m/f/d) role is embedded in the Global Regulatory Affairs Department at Sandoz Biopharmaceuticals. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of innovative medical devices which range from standard combination products to complex on-body and e-devices with associated software.

The ideal candidate for this role brings solid device regulatory experience (3-5 years), can independently drive regulatory stakeholder interactions (e.g. Notified Body, EMA, FDA) and can successfully 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 not limited to:
• 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
• Regulatory lead for the development / manufacture of medical devices, including management of relevant registration, certification, and audit requirements. Operational owner of medical device related deliverables and timelines
• Support the generation and maintenance of design history files and review these documents during development and post-marketing, respectively
• Liaise, as core member of the device development team, with other functions of medical device development to define and achieve the aligned strategy
• 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

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Advanced University degree or equivalent education/degree in life science/healthcare is required (minimum requirement Master’s degree or equivalent)
• 3-5 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 standalone 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?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 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.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!


Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.


Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
SANDOZ
BioPharma SZ
Germany
Holzkirchen (near Munich)
Research & Development
Full Time
Regular
No
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346519BR

Manager Regulatory Devices (m/f/d)

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