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Regulatory Affairs Coordinator
vor 2 Monaten
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sound United. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the EMEA region.
Key Responsibilities:
- Prepare and coordinate country submissions for medical devices in the EMEA region.
- Maintain and process EMEA renewals, changes, Free Sale Certificates, and other regulatory certificates.
- Review and prepare RA documentation according to economic operators' obligations under MDR in the EMEA region.
- Provide expert guidance on complex regulatory concepts to cross-functional teams.
- Ensure compliance to MDD/MDR in the EU and national requirements and international regulations.
- Update technical documentation according to regulatory requirements.
- Maintain regulatory affairs files and listing, and distribute information as required.
- Proofread, assemble, route, and archive regulatory registration files.
- Maintain schedules for renewal of regulatory certificates and licenses.
- Process and maintain requests for distributor letters.
- Maintain published regulatory records and databases.
- Assess the impact of changes to medical devices on national regulatory requirements.
- Support customer service, marketing, and sales with global market approvals.
- Support scheduling and arrangements for regulatory meetings.
Requirements:
- Knowledge of global medical device regulations, requirements, and standards.
- Proficient in Microsoft Office Suite, particularly Outlook, Excel, Word, and PowerPoint.
- Excellent verbal and written communication skills.
- Prioritizing, organizational, and interpersonal skills.
- Documentation skills, including record maintenance and tracking.
- A detailed-oriented individual with a 'can-do' attitude.
- Self-motivated and able to work autonomously.
Preferred Qualifications:
- 2-5 years of related work experience.
- Proficient in Salesforce and document control systems.
- Prior experience working with international organizations.
Education:
Bachelor's degree or equivalent combination of education and experience required. Preferred degrees in science, engineering, medical, or healthcare.
