Beschreibung
Regulatory Affairs, Specialist 3Duration: Until the end of the year with extension through 2023
Location: Solothurn
Tasks:
- Support MDR compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices to comply with MDR requirements
- Directing and coordinating activities concerned with medical device submissions and approvals to government regulatory agencies and notified bodies.
- Providing guidance to project team members regarding regulatory compliance issues by providing independent regulatory guidance, regulatory impact assessments and support for strategic planning and compliance activities.
- Overseeing the preparation and maintenance of regulatory files
- Preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Reviewing and approving proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Working with team members and commercial partners, provide RA guidance to New Product Development projects
- Interpreting medical device regulation (MDR) requirements
Qualifications:
- A minimum of a Bachelor's degree with 3-5 years of experience in regulatory affairs is required.
- Practical experience in a Medical Device Regulatory Environment is required.
- Knowledge of US and European regulatory processes is required.
- Experience with 510(k) submissions and/or Class II Technical files is required.
- Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
- Experience with Medical Device Regulation (MDR) is preferred.
- Experience in change management is preferred.
- Knowledge of international medical device requirements (China, Japan, Australia, Brazil, Russia, etc.) is preferred.
- Excellent written, verbal communication and presentation skills.
- English fluent is mandatory (all documentation in English)
- Strong knowledge and skills in MS Office
- Familiarity with Technical Documentation structure according to STED required
- Strong interpersonal and diplomatic skills
- Team work oriented, within a multi-functional and multi-national team
- Customer / service orientation
- High analytical, planning and organizational skills; able to set priorities
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.