Regulatory Compliance Manager - EMEA (Germany)

Confidential
  • Germany-Other
  • Confidential
  • 5-10 years
  • 94 Views
  • 07 Apr 2015
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  • Quality Control - Product/ Process, Compliance/ Regulatory

  • IT/ Technology - Software/ Services, IT/ Technology - Quality Assurance/ Testing
Job Description

Responsibilities:

Working closely with the Sales team on Strategic Sales efforts and helping to land the largest clients that CSOD has on a long term
Working closely with the client during the presales process to help positioning CSOD from a Regulatory compliance aspect and scoping services. Educating sales and implementation teams on regulatory compliance areas (Life Science, Healthcare, CFR, Energy, ISO, etc.)
Scoping of Engagements such as body of work and services, drafting SOW language and estimating cost/time for compliance efforts
Acting as the Corporate Quality Officer to the client (from a Regulatory Compliance aspect) during audits, responding to Audit findings, managing the audit remediation and ensuring the Audit cycle occurs
Managing and ensuring that Compliance related changes are on the roadmap for regulated clients, including new features / functions
Conducting quarterly Impact Assessments, also for Patches and Hotfixes (Future)
Delivering all services related to Regulatory Compliance to clients, validating toolkit, consulting services, maintenance, workshop and audits
Developing new services for Regulatory Compliance and update/retool existing services
Responsible for validations tasks such as annual Re-validation of CSOD's offering, automation of Validations process (future) and reviewing of all documentation and processes around validation
Validating automation, auditing quality Manual for CSOD and system specification for CSOD

Required Skills and Experience:

Bachelors' degree in Engineering or the Physical or Biological Sciences
5 years quality, compliance and regulatory experience in the medical device or other regulated manufacturing environment 3 years managing an audit program and conducting audits in the medical device or drug industry preferably in a corporate function
Demonstrated leadership ability and experience
Demonstrated ability to self-motivate Working knowledge/experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products
Applied understanding of QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive, and Canadian Medical Device Regulations (CMDR)
Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
Demonstrated ability to work effectively with a variety of work groups, including cross functional teams, to assure conformance to regulatory requirements, internal processes and procedures
Provides proactive guidance/advice and solutions regarding questions on compliance related issues to the organization
Fluent in English and German. Additional European languages a strong advantage