German Speaking Regulatory Affairs Submission Specialist- Medical Device

Contract Duration: 12 months with possibility of extension

Location: Lithuania

Kelly FSP is seeking a Regulatory Submission Specialist to support one of the world's top five pharmaceutical companies in the medical devices sector. This role involves coordinating and preparing regulatory submissions to ensure compliance with global regulatory requirements for medical devices.

You will be responsible for RA submission in Germany, Switzerland, Austria, Poland, and Lithuania for Cardiovascular and Neuro devices.

Key Responsibilities:

• Document Preparation:
• Prepare and submit documents for EC/CA in the assigned region.
• Initiate and review translations of documents (e.g., Patient Informed Consent).
• Adapt Country/Site Specific Patient Informed Consent forms according to regulatory and EC requirements and obtain internal approval.
• Interpret clinical study protocols for EC/CA submission using layman terms where necessary.

• Process Support:
• Act as the primary point of contact for EC/CA.
• Support document adaption per EC/CA requirements and manage responses.
• Assist in budget adaptation to meet country and site requirements.
• Maintain local regulatory documents and ensure they are uploaded to data management systems where applicable.

• Collaboration:
• Provide support to CSL and Clinical Project Teams.
• Assist in developing and reviewing informed consent documents to ensure all required elements are included.
• Support site activation document collection and approval processes.

• Administrative Duties:
• Attend, schedule, and document project-related meetings.
• De-identify and file adverse event source documents if applicable.
• Maintain the Clinical email box and disseminate emails appropriately.
• Support team personnel with site activation and closure activities.

• Communication:
• Communicate and collaborate with all levels of employees, customers, contractors, and vendors.
• Serve as a liaison to Clinical Site Management for administrative questions.

• Compliance and Quality:
• Support Company initiatives as identified by management and regulatory requirements (QMS, EMS).
• Comply with all regulations, Company policies, and operating procedures.

Education & Competencies:

• Educational Background:
• High school diploma/secondary school degree.
• Bachelor’s or Master’s degree from an accredited university or college, or relevant clinical research experience.

• Skills & Knowledge:
• Proficient with PC-based software (Microsoft Word, Excel).
• Experience with databases is preferred.
• Native German speaker with clear, understandable communication skills in German.
• Proficiency in English is required.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies and clinical research processes is beneficial.
• Understanding of German, Austrian, Swiss regulations, including Data Protection and Radiation protection.

• Personal Attributes:
• Discretion in handling sensitive/confidential information.
• Independent working capability.
• Strong verbal, written communication, and interpersonal skills.
• Ability to work in a fast-paced, changing environment and within a geographically diverse business model.
• Strong organizational skills and ability to prioritize tasks to meet deadlines.