Entwicklungstechniker/in

Your responsibilities

Core member of medical device and combination product development teams, providing high quality regulatory input to ensure that the developed product meets global Health Authority expectations

Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of MDR Article 117 Notified Body Opinion interactions

Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone medical devices.

Supports audit readiness activities and inspections for medical devices and combination products including obtainment and maintenance of certification for stand-alone medical 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 and combination products, including management of relevant registration, certification, and audit requirements. Operational owner of medical device and combination product related deliverables and timelines

Regulatory device lead for post approval phase, supporting global registrations, responsible for evaluation of changes, definition of implementation strategies and submission of variations

Strategic oversight of medical device and combination product regulatory activities - ability to lead others to ensure successful identification of device deliverables, completion of deliverables in-line with development milestones and successful integration into dossiers and successful response to health authority deficiency letters or requests for information

Essential Requirements:

Advanced University degree or equivalent education/degree in engineering or life science/healthcare is required (minimum requirement Masters degree or equivalent)

5+ year industry experience working in medical device/combination product 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

Proven track record of supporting development of medical devices or combination products starting from design planning through to design transfer

Experience in the generation of the technical file for stand-alone device submission or 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

Experience in the generation or review of Clinical Evaluation Protocols and Reports for medical device submissions

Fluent in English (oral and written) - with excellent verbal and written communication skills

Ability to lead others to achieve results in a complex highly matrixed environment

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

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 form of company transportation and shift buses

Company Kindergarden and summer camps for children

Wellbeing & mental health offers

Learning and development options for your personal and professional growth

Worldwide career opportunities

https://www.sandoz.at (Job ID REQ-10030778)