Are you ready to take your next step in your career? Then maybe this job that is a recruitment is something for you!The Staff Regulatory Compliance Specialist is responsible for planning, coordinating, and conducting quality system audits and support activities for compliance to federal, international regulations, standards (e.g., FDA QSR, FDA cGMP, ISO, etc.) and Company requirements. This role is also responsible for providing support for FDA, Health Aut... Visa mer
Are you ready to take your next step in your career? Then maybe this job that is a recruitment is something for you!The Staff Regulatory Compliance Specialist is responsible for planning, coordinating, and conducting quality system audits and support activities for compliance to federal, international regulations, standards (e.g., FDA QSR, FDA cGMP, ISO, etc.) and Company requirements. This role is also responsible for providing support for FDA, Health Authority and Notified Body inspections conducted, including readiness activities, front- and back-room participation/management and general inspection support as requested. Facilities include worldwide operations, including the United States, Europe, and Asia.
Location: Uppsala
Key Responsibilities
- Provide support to the segment in the performance of audits or audit related activities.
- Serve as company representative during regulatory inspections, including support activities such as actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
- Provide regulatory assessments of internal/external audit findings. Review/monitor correction, corrective, preventive, and effectiveness actions.
- Promote a culture of proactive compliance to regulations, standards, and procedures and risk management throughout the organization.
- Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and other leadership forums.
Qualifications
Education:
- Minimum Bachelor’s degree required in a scientific or engineering discipline or equivalent field
- Certifications preferred in ASQ-CQA, CQE or SCQE, ISO Lead Assessor, and/or RAC
Experience and Skills
Required:
- Minimum 6 years of relevant work experience
- Experience working in a quality assurance / compliance audit environment
- Experienced auditor in a Quality regulated environment
- Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments
- Experience managing and implementing robust Corrective and Preventive Action Systems
- Strong communication, organizational, negotiation, and interpersonal skills, with the ability to work cross-functionally and influence change
- Advanced English & Swedish Language
Preferred:
- Experience managing External Regulatory/Notified Body Inspections (e.g., FDA, ANVISA, PMDA, BSI, etc.)
- Understanding and knowledge of a broad set of regulations and standards (e.g., 21 CFR 820, ISO 13485, EU MDD/MDR, MDSAP, etc.)
Other:
- Requires up to 10% travel, domestic and international
About the company
The company is widely recognised for its dedication to benefiting global health by integrating compassion, scientific acumen, and creative innovation. Their objective is to revolutionize healthcare, paving a transformative path for humanity.
Their primary focus within its medical devices division is to broaden its reach, touching more patients' lives and aiding in a greater number of recoveries. With over a century's worth of pioneering advancements in patient care, they provide an unparalleled variety of products, services, programs, and a solid foundation in research and development. Their areas of expertise include surgical technology, orthopaedics, cardiovascular, and specialized solutions, all geared towards delivering significant clinical and economic value to healthcare systems worldwide.
Application process
Addilon is our partner in this recruitment. Please apply (CV and personal letter in English) via the link. We will fill the position immediately after finding the right candidate. Questions about the position are answered on weekdays 09.00-10.00, +46 10 207 43 20.
About Addilon
Recruitment and hiring of the right managers and specialists in mainly Engineering, Sales, Purchasing and Logistics in Stockholm, Gothenburg, Mälardalen, Helsinki, Copenhagen, Oslo and Chicago.
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