We are looking for a Senior Regulatory Affairs Specialist (w/m/d) for our client in Med-tech sector:
RESPONSABILITIES:
- Defines regulatory strategy
- Responsible for life cycle management projects
- Creates and maintains Technical Documentation (EU MDR) and US FDA submissions
- Assesses impact of changes on product registrations world-wide
- Supports creation and review of needed deliverable in accordance with the medical device development and change management processes
- Manage and align the development of regulatory strategies, participate in project teams, and serve as a contact person for regulatory requirements
- Maintain regulatory databases and ensure accuracy and completeness of regulatory data.
SKILLS:
- Bachelor's or Master's degree (PhD) in Pharmacy, Life Sciences, Medical device or related field
- Minimum 3 years of RA and/or QA experience in the medical device industry
- Experience in working with ISO 13485, MDR and FDA
- English (mandatory), any other languages are considered a plus
BENEFITS
- home office 2 days/week
- flexible working hours
- attractive salary
- flat hierarchy and decision maker
- 25+ holidays
CONTACT FOR THE APPLICATION:
- E-Mail: furchi@sciproglobal.de
- Tel: +49 (0)89 / 26200311
