Your key responsibilities:
In your role, you will collaborate closely with Quality and Regulatory as well as external manufacturing partners. You will also work with Product Lifecycle management of Pharmiva’s products, CMC, process development, design control and change control.
You will be responsible for development of new products and for existing products, to make sure they are following the regulatory requirements also including compliance with up-dated standards, guidelines and regulations throughout the lifecycle of the products by up-dating, reviewing and establishing engineering documents and Standard Operation Procedures according to the regulatory requirements. In this position, you will also manage material specifications from suppliers, lead risk assessments with multi-functional teams and perform different type of analysis both related to the manufacturing and development process.
You will report to the COO – Chief Operation Officer.
Your key qualifications:
To succeed in this role, we think you have minimum a technical academic background on a master level and relevant experience in the medical device industry. We also believe you have extensive “hands on” experience of medical device, technical documentation (design control documentation) and risk assessments as well as a good understanding of ISO 13485 and design control processes. We think it is important to have experience of Product Lifecycle Management, product development & project management within medical device.
A very good knowledge in spoken and written in English and good knowledge of MS Office and electronic document management systemis mandatory.
It is valued that you have a ‘go do’ attitude, where you are not afraid to visit a process at the floor and be hands on in during both manufacturing and development processes.
At Pharmiva we value personal skills as much as professional qualifications, and in this role, personality is crucial for success. You are good at working together with others and can express yourself well both spoken and written. You handle cases independently and you are a performance-driven person who can keep deadlines and deliver at a high pace. You are analytical, careful and aware of the details and quality. Furthermore, you are focused and structured and can quickly get involved in new tasks / questions. You also can review large amounts of information and make relevant priorities.
At Pharmiva you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization
You will be in our headquarter in Lund, Sweden.
Pharmiva is a Swedish FemTech company that develops new, innovative products in order to improve vaginal health. Our first, patented and CE marked medical device product Vernivia® will be launched soon for treatment of Bacterial Vaginosis. An infection that affects one third of all women in the age of 15-49 year. For more information, visit www.pharmiva.com
If you have any questions regarding this position, you are welcome to call COO Karoline Akerjordet at +46 723 00 1446
Please apply to the position no later than 31th March. Send your formal application letter with CV to firstname.lastname@example.org, Subject: R&D Application – Your name
Your key responsibilities: