Regulatory Affairs Manager - Labeling (m/f/d) | Medical Devices
In this position you will be mainly responsible for managing regulatory aspects of medical devices, focusing on compliance, regulations and published guidance documents. Furthermore, you will coordinate and manage translations and approvals by local regulatory experts and work as part of projects teams in order to create launch materials for new products and indications.
What are your tasks as "Regulatory Affairs Manager (m/f/x)"?
- Provide leadership for and manage regulatory aspects of medical devices, focusing on compliance of medical device materials with laws, regulations and published guidance documents.
- Work closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review processes, establishing consistent best practices and submission guidelines
- Coordinate and manage translations and approvals by local regulatory experts.
- Be part of project teams in order to create launch materials for new products and indications.
- Manage regulatory aspects of submissions and communications with health authorities, including promotional materials.
- Develop and implement corporate policies and procedures for regulation materials and other external communications/press releases
- Monitoring compliance trends, advise internal stakeholders on relevant new and regulatory risk and compliance requirements, provide support to Sales and Marketing and related teams
What does the position offer to you?
- Exciting projects & personal development
- Flexible work hours
- Pension plan and childcare
- 30 vacation days & 6 additional compensation days
What requirements do you need for "Global Regulatory Affairs Lead (m/f/x)"?
- Bachelor's degree in scientific or health discipline, preferably M.S. or higher
- At least 3 years of pharmaceutical/medical technology industry experience and a minimum of 1 years as a regulatory affairs reviewer of labelling materials
- Strong knowledge of EU and ROW regulations and guidance pertaining to medical device labelling
- Proficiency in all MS Office applications
- Excellent organisational, prioritisation and planning skills
- Ability to work independently on projects and initiatives internally and with external vendors
- Confidence and the capacity to influence key stakeholders
- Excellent language skills in German and English (written and spoken)
About the client?
Our client an independent, family-owned company, and a market leader across multiple therapeutic areas. Based on over 110 years of experience, they are a global leader in therapeutic innovations that empower patients to live fully and achieve their individual goals.
Are you interested in such company? Then you should apply now! If you would like to receive Information, I would be happy to let you more about it and other opportunities:
Contact for application:
- E-Mail: email@example.com
- Tel: +49 (0)89 / 26200311
- LinkedIn: https://www.linkedin.com/in/marianna-furchÃ¬-90872750/