Permobil founder Dr. Per Uddén believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users’ needs and improving their quality of life through state-of-the-art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs. Permobil is part of Patricia Industries, a subsidiary of Investor AB and is headquartered in Sweden. Permobil has 1600 team members in more than 15 countries around the world. For more information regarding the company’s storied history and complete product line visit permobil.com.
The Quality Assurance & Regulatory Compliance-department at BU Power Products is expanding and is now searching for a new Regulatory Specialist.
In this role you will collaborate in cross functional teams together with mechanical, electronics and software development engineers, product managers, QA Managers and other stakeholders to ensure the regulatory compliance of our Medical Devices. You will be responsible to assure from a regulatory perspective all steps in the Design Control process, from stating and reviewing specifications, making sure that all regulatory requirements are accounted for to finally assessing regulatory compliance before design transfer to production.
As a Regulatory Specialist, you will assure that process and product compliance is maintained through proper processes within the Quality Management System (QMS) following Medical Device Regulation (MDR), Quality System Regulation (QSR) as well as other applicable regulations.
• Perform regulatory assessments in new development projects and design change projects
• Advise project teams on premarket regulatory requirements, export and labeling requirements, and/or clinical study compliance.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Put together 510(k) applications for compliant registration of our medical devices on the US Market.
• Draft EU-declarations of conformity and evaluate all necessary documentation needed for signing the EU-declaration of conformity such as General safety and performance requirement checklists and Technical Documentation for compliant CE marking of our Medical devices.
• Develop, manage and review regulatory processes within the QMS, and ensure that they are compliant to all applicable regulatory requirements.
• Review product promotional materials and labeling for compliance with applicable regulations and policies.
• Perform regulatory review and approval of records from QMS processes where applicable
• Investigate non-conformance issues and CAPA
• Identify training needs and organize training in Regulatory Compliance
• Support organization regarding Regulatory Compliance issues
• Interpret and implement assigned standards and regulations
• Participate in internal and external audits
You will be a part of a team reporting to the Director of Quality Assurance and Regulatory Compliance, and interact with all parts of the company as well as competent authorities, notified bodies etc.
You have a university degree in science or engineering. You have working experience, preferably from Med Tech or Pharma industry and/or have good knowledge of quality management systems.
As a person you are a team-oriented problem solver with organizing skills and attention to detail. You have great communication skills, which you will use both in investigations and when performing training.
You are fluent in oral and written Swedish and English.
For more information about the position, contact Sofie Petersson, Director QA & RC, 070-9105776
For information about the recruitment process, contact Anna-Karin Ehn, HR Business Partner, 070-3271838
For contact with union representatives, please email: email@example.com
Please submit your application via our career page, no later than 20th of February.