Regulatory Affairs Specialist

Caesarea

Digital SPECT Imaging Solutions Innovations that provide the foundation for the next generation of nuclear medicine scanners. Introducing a true paradigm shift in design, workflow, and diagnostic capabilities.

Spectrum Dynamics Medical, as the inventors of 360° CZT for multi purpose whole body scanning, Spectrum has demonstrated once again its spirit of innovation, agility, and execution. Our products are key to higher clinical confidence, unlocking future research applications, and potentially better and less expensive care to benefit both patients and providers.

About the job

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]