QA/RA Specialist - EMEA
Position Overview
Ensure that medical devices meet the current standards and regulations and provide Regulatory Affairs oversight for regional countries in EMEA. Job duties:
- Provide support for international registrations (outside EU, for new devices launch and change notifications):
- Prepare product registration documentation using technical and legal documents supplied by Corporate.
- Maintain up-to-date Registration documents for international registration.
- Prepare and submit the amendments including periodic renewals and revisions of previously registered products.
- Stay updated on information regarding new technology and any major regulation changes which may have potential regulatory/business impact.
- Help transition locally from MDD to MDR.
- Support the Sr QA/RA Manager in maintaining a QMS that meets the applicable regulatory and company requirements including ISO 13485/EU regulations.
- Assist in the creation of standard operating procedures and work instructions for MVE if needed.
- Under the supervision of the Sr Manager Specialist RA/QA, support relationships with Authorized Representative outside of the EU (e.g., UK, Switzerland, etc.) and provide necessary support.
- Under the supervision of the Sr Manager Specialist RA/QA, support cross-functionally with other departments to achieve goals and support the business.
- Assist in maintaining document control system to be up to date.
- Assist with regulatory issues such as recalls or field safety corrective actions and advisory notices.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.#LI-DNI
- Minimum one (1) to two (2) years of relevant work experience.
- Knowledge of EU regulations and standards, such as (but not limited to) MDD, EN ISO 13485.
- Previous experience that demonstrates the ability to prepare product registration documentation.
- Strong team player providing support, guidance, and expertise in achieving regulatory compliance.
- Cultural awareness: Ability to switch among cultural frames of reference and communication mode.
- Hands-on, constructive, and forward-looking attitude.
- Strong written and verbal communication skills.
- Attention to detail; good organization and planning skills.
- Demonstrated ability to meet deadlines.
- Autonomous with strong capacity to take initiative and responsibility for action.
- Advanced verbal and written English language skills.
- Proficient with MS Word, Excel, Teams, and Outlook.
- University degree in science or a closely related field of study.
- Ability to use and understand other languages.