Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Regulatory Affairs Manager overseeing medical device registrations and compliance for AVIA Pharma's products. Collaborating with internal teams and external authorities to ensure regulatory adherence in healthcare.
Responsibilities
- Responsible for the approval and registration of our medical devices (Class I/IIa under the MDR) and participation in dietary supplements/cosmetics
- Preparation, maintenance and review of technical documentation
- Ensuring compliance with all relevant regulatory requirements
- Review and approval of packaging and promotional materials
- Close collaboration with internal departments, external consultants, authorities and Notified Bodies
- Active monitoring of regulatory developments and identification and implementation of necessary actions
- Support during audits and inspections and assistance to Quality Management
Requirements
- Degree in Pharmacy, Chemistry, Biology, Medical Engineering, Food Chemistry or a related field
- Professional experience in Regulatory Affairs, ideally with a focus on medical devices
- Knowledge of dietary supplements and cosmetics is an advantage
- Strong knowledge of relevant EU regulations/standards
- Experience in liaising with authorities/Notified Bodies
- Excellent spoken and written German and English
Benefits
- Coffee, tea & water – unlimited during working hours
- Team events – we promote team spirit because we are stronger together
- Option to work in a mobile office (remote/hybrid work option)
- Birthday gift – because everyone is special
- Company pension scheme – thinking of tomorrow today
- Subsidy for computer glasses – so everything is clear and easy to read
- E-bike/bike leasing – cycle to work
- eGym Wellpass – promoting your well-being
- Special leave – for various occasions such as birth, marriage, bereavement
- 30 days of annual leave per year
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
Senior Tech Compliance Analyst at Syneos Health responsible for global Technology Disaster Recovery efforts, collaborating with various teams and service providers.
BL
Chief Nuclear Officer serving as the nuclear safety authority for BaRupOn's SMR/MMR programs. Establishing safety frameworks and ensuring regulatory compliance within the organization.
International Trade Compliance Manager overseeing compliance with international trade regulations at Northrop Grumman. Leading a team and managing compliance initiatives across multiple locations in the US.
Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.
Compliance Student supporting compliance and risk management activities for individual insurance at iA Financial Group. Involves monitoring processes, collaborating with teams, and assisting with compliance tasks.
Nurse Licensure & Compliance Coordinator managing multi - state nurse licensure and compliance inquiries while ensuring a positive nurse experience. Advocating for nurses and maintaining regulatory adherence at the organization.
508 Compliance Specialist working with the Office of the Inspector General for the DoD. Responsible for ensuring electronic accessibility for compliance with Section 508 regulations.