Job Description Summary
Regulatory Affairs Device Manager (d/f/m) | Kundl, Austria
Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!
The Regulatory Affairs Device manager (d/f/m) role is embedded in the Global Regulatory Affairs Department at Sandoz. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of medical devices which range from simple drug administration products to complex needle-based injection systems and on-body devices.
Your Key Responsibilities:
* 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.
What you’ll bring to the role:
Essential Requirements:
* Advanced University degree or equivalent education/degree in life science/healthcare is required (minimum requirement Masters degree or equivalent).
* 3-5 years 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 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 to coordinate deliverables cross-functionally.
* Can clearly communicate complex topics to other experts/stakeholders.
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.
You´ll receive:
* Attractive salary with incentive program.
* Modern company pension scheme.
* Flexible working hours/home-office depending on the position.
* 14 weeks of paid parental leave.
* Additional days off (bridge-days).
* Subsidized meals in our canteen.
* Sustainable mobility in the form of company transportation, shift buses and car sharing.
* Company Kindergarten and summer camps for children.
* Wellbeing & mental health offers.
* Learning and development options for your personal and professional growth.
* Worldwide career opportunities.
In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position, the minimum salary is EUR 64.023,54/year (on a full-time basis). In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Are you ready to join us? Then we look forward to your application!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com.
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: Sandoz Talent Pool
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Skills Desired: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance
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