We are currently seeking an experienced Vigilance Specialist to join our HQ Quality team, reporting to the Global Regulatory & Compliance Manager (placed in Porto Portugal). This role requires ensuring compliance with laws, rules and regulations as part of continuous improvement to ensure compliance with all US and EMEA.

Responsibilities
•    Internally tracking and trending of customer complaints within the Compliant handling system.
•    Processing complaint investigations once received from R&D and communicate the conclusions to authorities in an appropriate manner.
•    Ensure timely closure of complaints to comply with European and US requirements as well as other applicable regulatory bodies and countries.
•    Support effective Risk management by PMS, ensuring release of safe devices to the market.
•    Support preparation of routine metrics (e.g. monthly) for site and EMEA regular reports.
•    Ensure compliance with all US and European regulations governing adverse event reports such as well as reportability requirements for various countries world-wide.

Qualifications (Education, experience and skills):
•    Bachelor's degree in Quality Engineering, Quality Management or similar. 
•    Experience of working with medical devices, their use and post-market surveillance activities. 
•    Fluency (near native) in English (written and spoken) on a level of contract negotiation is required.
•    Advanced knowledge of MS Office tools (Word, Excel and Power Point) and Familiarity with complaint handling systems, especially EtQ Reliance (preferred).
•    Knowledge in record keeping, procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations (preferred).
•    High level of analytical skills to get problems into perspective.
•    Ability to stay calm in stressful situations, work as part of a team and have good personal relationships.

Interested?
If you are interest in this full-time hybrid position, please send us your resume to recrutamento.pt@invacare.com, with the reference code VS_2024 in the subject line.

About us:
Invacare is a leading and innovative healthcare solutions provider that caters to the needs of individuals with mobility challenges. With a strong presence in Europe, Invacare's dedicated to enhancing the quality of life for people with disabilities and those requiring home healthcare solutions. Our commitment to delivering advanced mobility products, assistive devices, and personalized services has positioned us as a trusted partner within the healthcare industry. Join our team and be a part of our mission to empower individuals and improve accessibility for all.