Regulatory Affairs Specialist

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 (http://www.permobilus.com/).

We are now recruiting a Regulatory Affairs Specialist!

Regulatory Affairs is a part of Group Q&R and serve as support globally for the different regional Permobil organizations.

The Regulatory Affairs team is responsible to manage the registration of our products in countries where we intend to market our products, often through support or cooperation with our local sales organization or distributor partners. The team is also responsible for keeping up to date with current and future regulatory requirements and legislation's and to actively monitor, interpret and communicate the regulatory requirements into quality system and product requirements. Communication with various competent authorities such as in vigilance cases, submission or as part of audit preparation is an key part of our responsibilities.

Group Q&R is actively supporting the Regional QA/RC teams with compliance activities and are coordinating compliance audits across the Permobil organization globally. The group is also actively taking part in the product development process supporting with regulatory strategies, participation in clinical evaluation teams and managing pre-submission and submission activities.

Location of the position is preferably in the office in Kista, Stockholm but it is an international work scene and some travelling will be needed.

Key tasks as Regulatory Affairs Specialist

- Manage product registrations
- Coordinate pre-submission and submission activities
- Standard and directive monitoring
- Support function for various Regulatory Affairs issues within the company
- Regulatory support during Design and development
- Regulatory Change Assessments
- Coordinate and perform compliance audits
- Assist with audits of suppliers
- Vigilance reporting


Qualifications and Skills:

- Bachelor's degree or higher university education or equivalent in relevant field.
- At least 3 years' experience of work in Regulatory or Quality either from Med Tech industry or health authority.
- Excellent communication skills
- A proactive and positive approach to teamwork and communication
- Knowledge of QSR (21CFR 820), ISO 13485 and CFDA
- Very good knowledge in the English language both verbally and in writing
- Well organized, in possession of an inquiring mind and analytically strong able to make decisions based your own analyzes.
- Having the power of initiative with the ability to work independently and take responsibility of you own work
- You have a well-developed skill in building constructive relationships and have the ability to coordinate and cooperate in an global environment.


It is considered a merit if you have previously worked with:

- Submissions and registrations of medical devices
- Vigilance reporting
- Medical device product development projects and clinical evaluations


Information

If you have any questions about the position or the recruitment process, please contact our recruiters for this position Tomas Löfgren, tomas.lofgren@jeffersonwells.se, +46 8 764 2585 or Anna Setterberg, anna.setterberg@jeffersonwells.se, +46 725598129.

Please apply no later than June 23, 2021.