Regulatory Specialist, Direct Healthcare Group

Do you have a background within Regulatory Affairs and want to be a part of an expansive journey in a company active on the global market of medical devices? Then you should apply for the position as Regulatory Specialist at Direct Healthcare Group (DHG).

DHG is a medical device company situated in Stockholm acting on several national markets. The company provides effective movement-based, medical device solutions that increase life quality across care and living environments.

About the position
As Regulatory Specialist you have the overall responsibility to ensure that the business complies with the quality requirements in accordance with associated regulations, MDR requirements and other applicable guidelines/standards. Main tasks include:

• Being Authorized Responsible to ensure all product categories and processes comply fully with MDR 2017/745.
• Being PRRC for all the product manufactured within EU.
• Performing and maintaining all medical device registrations.
• Reporting and coordinating any recalls or adverse events to relevant competent authorities.
• Responsible for ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
• The post-market surveillance obligations are complied

Your profile
The right candidate is curious, responsible and thorough. You feel comfortable with planning and prioritizing different tasks in order to work in a self-driven manner.

Qualifications:

• Minimum bachelor’s degree in pharmacy, medicine, chemistry, technology or other natural sciences related field.
• At least 2 years’ experience from Regulatory affairs in the Medical Device – alternatively Pharmaceutical industry.
• Understand the Medical Device Regulation (MDR) and other relevant authority regulations
• Knowledge about implementation of ISO 13485.
• Knowledge about the FDA, QSR and other countries' requirements for medical device manufacturers.
• Professional level in both written and spoken English (Swedish is desirable).

To succeed in this role you sympathize with the company's values: Be open in your communication, take initiative, be responsible and work together in teams and implement it in your way of working.

Recruitment Process
In this recruitment Direct Healthcare group is collaborating with Mpya Sci & Tech. Please send in your application as soon as possible. If you dont have the possibility to do so or if you have any questions, please do not hesitate to contact our talent advisors.

Ellinor Crafoord, Ellinor.crafoord@mpyascitech.com, 072-1765167
Matilda Brink, Matilda.brink@mpyascitech.com, 072-36 348 81