Product Complaints Specialist

Are you looking for a great career and want to make your mark?
Please keep on reading but don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for!
Could you help improve healthcare outcomes around the world?
If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below.
To further enhance our performance, we are now hiring a
(Part time 50%) Global Product Complaints Specialist
This is a global role and can be performed remotely from anywhere in Europe, or at any of our European offices.
This is a possibility for a student to grow into the profession while studying or a professional to find a challenging role still have time to other passions in life.
The purpose of the role is to ensure patient safety by providing a comprehensive and effective product complaint handling, Field Action planning and execution and incident reporting.
This is achieved by working closely with QA and RA management:
Secure compliance with internal and external requirements for Medical Devices and Pharmaceuticals.
Handle product complaints in a satisfying and proactive way.
Address necessary corrective and preventive actions.


The role will also, together with the Global Product Complaints Manager, drive as well as develop the vigilance, pharmacovigilance, product complaints handling competence within the entire Mölnlycke organization.


KEY ACCOUNTABILITIES
Drive and coordinate as well as document product complaints activities including receipt, initial assessment, data in feed, analysis, review and follow up
Perform incident reporting
Interact with internal stakeholders and pro-actively contribute to the Post Market Surveillance plan and other improvement activities
Interact with external stakeholders e.g. Competent Authorities and Notified Bodies regarding incident reporting and other product quality issues.
Together with Lead Product Complaints Specialist regularly analyze and report trends in product complaints data to identify new and/or systematic quality issues.
Actively contribute to improvements or development of existing Product Complaints processes and procedures
Participate in audits/inspections and contribute to progress and closure of corrective actions.
Actively contribute to increased product quality, and complaints handling knowledge within the entire organization
Keep up to date with relevant international legislation and guidelines
Directly and frequently communicate and interact with internal stakeholders within RA, QA, R&D, Operations and Commercial organization. relating to the function
Identify, apply and improve system and tools so that user experience and effectiveness can be enhanced


CAPABILITIES; QUALIFICATIONS AND EXPERIENCE
Academic background in life sciences, chemistry, quality management or regulatory affairs
Experience from work in an international environment
Background in medical devices and/or pharmaceuticals with post-marketing surveillance, complaints handling and/or voice of customer experience
Knowledge and experience in medical devices and pharma regulations
Key competencies include but are not limited to:
Detail oriented with analytical skills
Performance driven
High communication skills with a patient safety oriented and problem solving mindset.
Strong team player with high flexibility
Quality, regulatory and process knowledge
High computer proficiency
Good Distribution Practice


APPLICATION
Please submit your application as soon at earliest convenience as we are continuously going through applicants.

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialise in:
•Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
•Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
•Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.