Regulatory Compliance Intern working with Qonto to ensure compliance in eight European markets. Supporting payment compliance and regulatory watch tasks under a dynamic fintech environment.
About the role
- Quality & Compliance Manager responsible for leading QMS oversight and regulatory compliance for Dutch Ophthalmic USA. Ensuring effective quality strategies across three US locations with a focus on continuous improvement.
Responsibilities
- Set the organizational and compliance strategy for the QA organization in the US in collaboration with the Zeiss Global Quality team.
- Ensures that the commercial and distribution activities are conducted per a QMS that ensure compliance to federal and state regulations for devices and pharmaceutical products.
- Manage and harmonize the QMS across the three US sites while respecting each site’s unique processes.
- Develop, implement and maintain quality policies and documentation.
- Acts as the local representative of DORC for regulators in North America on Quality and Compliance topics.
- Accountable for verification that DORC products that are released for distribution on the US market meet specifications and regulatory requirements such as ISO13485 or FDA regulations.
- Accountable for timely and effective executing and reporting of field corrective actions in North America.
- Executes management oversight on all locations in North America where DORC carries responsibility for FDA regulated activities.
- Reports to HQ on the effectiveness and level of compliance in DORC sites in North America through management review and other management oversight meetings.
- Drives continuous improvement of QMS governed processes aimed at increasing efficiency, effectiveness, harmonization and compliance.
- Prepare for and host external audits at DORC sites in North America and drive resolution of associate non-conformities.
- Address non-conformities and implement corrective actions.
- Educate, train and advise the organization on quality and compliance matters.
- Initiate improvement projects & initiatives.
- Timely escalation and resolution of quality or compliance concerns.
- Act as Management Representative for US.
- Lead, direct and train the quality team members.
- Oversee risk management strategies (tbc).
Requirements
- Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industry.
- Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.
- Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.
- Ability to effectively translate quality requirements into practical directions for the organization.
- Experience in management of FDA and/or Notified Body inspections.
- High level of integrity and ethical standards.
- Ability to multi-task and methodically manage projects based on business priorities and resource availability.
- Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.
- Collaborates effectively across a diverse network.
- Open-minded for improvement opportunities and change towards striving for best-in-class compliance performance.
- Ability to think creatively, proactively identifying alternative solutions to problems.
- Experience in people management.
- Effective communication/interpersonal skills.
- Fluent in English (written and spoken).
- Advanced level in Microsoft Office suite applications.
Benefits
- Medical – 90% employer paid
- Dental – 100% employer paid
- Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
- Vision
- 401k Matching
- Paid Leave: Sick, Vacation and Holidays
Job title
Job type
Experience level
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