Regulatory Affairs Specialist

Company Description

Spectrum Dynamics is transforming Nuclear Medicine from analog to digital technology, enabling clinicians to offer superior healthcare services with improved image quality and efficiency at lower doses. The company offers cutting-edge products such as the D-SPECT®, a digital cardiac SPECT system featuring swiveling CZT digital detectors, and VERITON-CT®, a digital 360° CZT-based SPECT/CT system with high-resolution CT. These innovations provide advanced applications for myocardial flow reserve analysis, attenuation correction, and dynamic SPECT imaging, accommodating patients of all sizes while continuing to evolve with higher energy ranges and superior imaging quality.

Role Description

The Regulatory Affairs Specialist will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.

Position Responsibilities 

• Preparation and maintenance of regulatory submissions and registrations for Spectrum Dynamics Medical products in relevant markets.
• Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; provide a technical review of data or reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Preparation and maintenance of annual renewals for Establishment Registrations, Device Listings, and other relevant regulatory licenses.
• Provide ongoing regulatory support and assessments for various processes related to QMS (such as CAPA and contract review).
• Be involved in evaluating changes to Spectrum Dynamics Medical’s QMS documents and device design/process to determine their impact on pending or existing registrations.
• As required, provide support for all external and internal audits at HQ and globally.
• Provide guidance to project teams regarding premarket regulatory requirements, labeling requirements, and/or other compliance issues.
• Ensure regulatory compliance by monitoring and advising the organization on upcoming or new guidance, regulations, agency/industry initiatives, etc.
• Address any other regulatory-related requirements as necessary.

Experiences, Knowledge, Skills, and Abilities 

• BSc degree in scientific / technical discipline / engineering.
• At list 1 year of Regulatory Affairs experience with the US FDA and EU regulatory agencies
• Prefer additional knowledge for regulatory submissions for Japan, China, Canada, South Korea, Taiwan, etc.
• Solid organizational, analytical, technical and problem-solving skills
• Experience working in a medium size global company is preferred
• Fluent (proficient) in English. Excellent written and verbal expression skills.
• Responsible, self-motivated, organized and meticulous
• Able to multitask and meet the targets set

Applications 

• Please submit job applications by email to [email protected]