DirecciónJob Description
Job purpose
Compliance with regulatory, legal and normative requirements for SMS. Review and cooperation in the preparation of the technical documentation.
Ensuring product approval in accordance with country-specific regulations.
Main accountabilities and tasks
- Observation and management of standards and directives, information on changes
- Participation in system maintenance of ISO 13485
- Assisting in the implementation of the requirements of authorities, directives, customers and standards
- Technical clarification and assessment of customer and authority requirements.
- Preparation and maintenance of system documentation.
- Technical documentation of customer and own projects, checking and cooperation in completeness and technical correctness before and during the preparation of evidence as well as before its archiving.
- Cross-site technical expert for assigned technical documentation topics.
- Cross-location expert for country requirements for assigned regions
- Implementation of worldwide product approvals
- Collaboration in the creation of customer contracts, such as delivery agreements.
- Support of the line offices in the creation of specification, template and proof documents.
- Collaboration and support of the medical device manager for medical device topics.
- Cooperation and support of the lines with medical device and industrial product topics.
- Contact to authorities, e.g. for inquiries, registrations and certifications.
- Duty to report to superiors, situatively to the line, in case of violation of legal compliance in medical devices issues.
- Ensuring the technical correctness of results and recommendations.
- Obligation to report via application procedure to superior, to CIP, misconduct of line offices, deficiencies in projects, etc.
- Preparation and implementation of specialist employee training (GMP, hygiene, standards, etc.).
- Participation and performance of internal audits.
- Ensure compliance with laws and regulations regarding environmental protection, fire prevention as well as occupational health and safety.
- Ensure reporting to the manager or ESH responsible person of ESH deficiencies and hazards (affecting working materials and funds as well as the working environment) which cannot be self-rectified
Qualifications
- Completed studies, ideally in the field of medical technology or life sciences
- At least 3 years of professional experience on global / international level in Regulatory Affairs in the medical device environment
- Expert knowledge of the regulatory requirements MDD / MDR, FDA, 21 CRF 820, CMDR, ISO 13485
- Good command of communication in English (written and spoken), German knowledge - advantage
- You are an assertive, communicative personality and an organizational talent
- Your are independent professional, with structured way of working
- Ability to travel (up to 10%)
Additional Information
- Hybrid working model
- Opportunity for your development
- Great team and working atmosphere
medmix is an equal opportunity employer, committed to the strength of a diverse workforce.
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Hace 2 horas
