Sr Regulatory Affairs Specialist

SHL Group designs, develops and manufactures medical device for the administration of medicines. The products are developed on customer assignments. SHL Group's site in Nacka carries out design and development projects for new products and work primarily with customers in the European market. Manufacturing of these products occurs in production sites in Taiwan or China.

The position:

The Department of Regulatory Affairs and Compliance in Nacka consists of 4 people and supports the entire global SHL Group with regulatory expertise in regard to the European regulations. The group works very closely with the Quality Assurance department with an additional 6 people. In the role as Senior Regulatory Affairs Specialist, your main responsibility is to support development projects in the aspect of regulatory strategy and design control.

SHL Group develops its products on behalf of customers in the pharmaceutical industry, why it is important to be confident in the legislation for both pharmaceuticals and medical device as well as to handle customer requirements.

In the role you will collaborate and interact with most of the functions and departments of SHL Group as well as with SHL Group's customers, therefore good communication skills and a solution-oriented approach is important.

Qualifications:

• Academic degree in technology or science or equivalent

• 3 years of experience in Regulatory Affairs

• Experience working with Medical Device

• Fluent Swedish and English in speech and writing.

SHL Group offers a senior specialist role where you get to work in a growing organization with high-tech products. SHL Group is an organization with ambitious team players who and have fun together. SHL Group also offers good terms and benefits.

Interested?

Please submit you application no later than 18 th of februari. Contact Talent Advisor Ellinor Crafoord at +46721765167 or ellinor.crafoord@mpyascitech.com for further questions.

About SHL Group:

Established in 1989, SHL Group (Scandinavian Health Limited) is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems such as auto injectors. With several distinct group companies, our product line ranges from injectors to pressure mattress systems, to laboratory handling equipment to neurosurgical devices. SHL Medical designs and manufactures advanced products for injection and inhalation of drugs and is the world’s leading supplier of auto injectors. With sites in Taiwan, Sweden, USA and

Switzerland, SHL Medical serves the world's largest pharmaceutical and biotechnology companies. SHL Medical employs more than 3 800 worldwide, with around 120 employees at SHL Group AB in Nacka Strand. SHL Healthcare develops and manufactures equipment solutions for home, hospital, and long-term care use with a focus on patient comfort and functionality. SHL Healthcare's main production site is in China, where we have close to 250 employees. At SHL Healthcare AB's office in Nacka Strand, we have 10 employees. För mer information om SHL Group, besök http://www.shl-gro