Are you hard-working and motivated, looking to kick-start your career? Would you like to work in a company at the forefront of medical innovation? Apply for the role as Quality and Regulatory Manager today!Dina arbetsuppgifter
In the exciting role as a regulatory manager you will be responsible for developing and maintaining the Quality Management System and you are the management representative on the area. Your key responsibility as a regulatory manager is to oversee and ensure compliance to regulations related to software and medical devices. The role includes a lot of text processing and working close with the technical documentation.
You will work closely with the Senior Regulatory Consultants and device development engineers during the conceptualization, development and commercialization of the device. You will be provided with all essential resources for learning and developing in the given task, and you will work closely with the Vice President of the company and the site lead in Sweden.Responsibilities
- lead the regulatory work preceding the launch of new products, to ensure compliance with the regulation of the US and EU market
- work with colleagues as well as third party regulators to create and submit regulatory registration documents
- provide guidance and advice to team members, as well as developing strategies for product submissions
- develop, maintain and enhance regulatory procedures and processes to ensure regulatory compliance
- monitor the regulatory environment and maintain the regulatory documentation for license registration renewals.
To succeed in this role, you should have the following skills and experience
- MS in Engineering, Law, Medicine or another relevant scientific discipline
- Excellent written and communication skills in English
If you have professional experience in the medical industry or in quality management that is a strong qualification.
Other essential skills and experiences required:
- Possess excellent written and verbal communication skills - ability to convey and present complex information to others clearly and logically.
- Demonstrate strong project management skills including planning, prioritization, problem solving, and decision making.
- Be a good team player with ability to build strong and constructive relationships both throughout the company and externally.
- Results oriented, with an ability to work to a high quality standard and possess a high level of attention to detail.
- Apply strategic thinking
- Be willing to travel between Sweden and the headquarters in New York.
The placement is a full-time position, located in central Lund.
Commencement date: January
Working hours: 8-17, flex
Do not miss this unique opportunity - apply today!