Regulatory Affairs Officer

3d3 days ago

Sectra

Linköping, SE · Full-time

About this role

Are you a person with an eye for detail and a strong sense of order? Do you want to develop personally and professionally at an international company in growth where your work contributes to a healthier and safer society? We are now seeking additional specialists in Regulatory Affairs with focus on the medical device market primarily in the EU and North America.

Sectra contributes to increased efficiency in healthcare and strengthened stability in socially critical functions. Our Operational Excellence team plays an important role in ensuring the organization works effectively, delivers high quality and meets applicable requirements and regulations on our markets.

The goal is to ensure that the products and services Sectra sells are safe and effective for our customers and their patients. Our team consists of eleven people in Linköping and an additional five people in our subsidiaries outside Sweden, all working dedicatedly with quality work of various kinds.

On Sectra we always prioritize attitude and ability when recruiting. We look for a willingness and ability to learn new things and take on new tasks and challenges quickly, along with a strong analytical approach and the ability to communicate smoothly with colleagues, partners and customers.

Requirements

Master's or bachelor's degree in relevant area, preferably engineering or medicine
Good ability to write formal texts in English such as policies, reports, processes and routines
Analytically inclined while being accurate and structured
Very good knowledge of Swedish and English in both speech and writing

Responsibilities

Keep up to date with applicable laws and standards for medical devices and ensure Sectra complies with them
Apply for and maintain market authorizations for Sectra's medical devices on intended markets
Handle external reporting of clinical incidents
Manage contacts with national authorities that regulate and supervise medical devices
Act as internal advisor regarding laws and regulations in the medical device area
Plan and participate in external audits
Handle deviations from audits and operations and follow up corrective and proactive actions
Actively advocate for our management system and support the business with continuous improvements

Benefits

Develop personally and professionally at an international company in growth
Strong company culture focused on customer benefit and making a difference
Work with colleagues who are passionate about improving healthcare and societal functions