Regulatory Manager overseeing the preparation and submission of documents to global health authorities. Ensuring timely regulatory submissions in a collaborative biotech environment.
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
Field Compliance Supervisor working on OSA framework contract in the Inner M25 region. Supervising safety and compliance for Telent's network services in London.
Compliance Coordinator supporting Healthcare Compliance initiatives at EXL. Ensuring compliance with ethical, legal, and regulatory requirements.
Deputy Environmental Compliance Manager ensuring compliance and project support for complex environmental projects. Delivering sustainable solutions within a client - focused environment at Atlas.
Audit and Compliance Analyst responsible for program compliance and policy development within healthcare services teams. Collaborating on auditing, monitoring, and report development regarding Care Management and Utilization Management.
Compliance Advisor in Asset Management Compliance focusing on regulatory policies and private investments. Supporting compliance activities and interactions across investment teams and legal departments.
Professional for strategic legal advice on data protection, privacy and compliance at Unimed. Involves implementing LGPD programs and engaging with business areas for compliance.
Compliance and Risk Manager overseeing government compliance programs within aerospace and defense environments. Responsible for risk management and ensuring adherence to regulatory requirements across multiple locations.
Regulatory Affairs Franchise Leader driving global regulatory strategy across APAC, MEA, Eastern Europe, and LATAM for Pierre Fabre's pharmaceutical products.
Intern supporting compliance and analysis in the banking and finance sector. Assisting in fraud cases, complaints resolution, and data analysis.