Technical File Reviewers-Medical Device Directive (MDD)

Om Intertek
Intertek är en ledande global leverantör av kompletta kvalitetssäkringslösningar. Vårt nätverk av mer än 1 000 laboratorier och kontor och över 40 000 medarbetare i fler än 100 länder levererar innovativa lösningar inom kvalitetssäkring, provning, inspektion och certifiering skräddarsydda för våra kunders verksamhet och leverantörskedjor. 
Bringing quality and safety to life

 

Intertek are looking for thorough individuals, focussed on delivering accurate and robust assessments within agreed timeframes and experienced within the medical device area, to take on the role as reviewers of medical-technical documentation within Intertek’s Swedish Notified Body for MDD (93/42/EC). If you want to be part of our journey, we would love to hear from you!

About Us:
Intertek is the trusted advisor to many of the world’s leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Our services take us into nearly every field, from textiles, toys and electronics, to building, heating, pharmaceuticals, petroleum, food, cargo scanning and medical devices.

In a world where a company’s success depends on its reputation for quality, safety, and socially responsible products and processes, Intertek employees make a difference.

Join the team at Intertek and work with some of the best, brightest, and most inspiring people in the testing, inspection, and certification industry.

The Role:
The Notified Body within Intertek Semko AB is accredited to certify companies according to the EU Medical Device Directive (MDD). Reviewing documentation, assessing products, performing quality management system audits and unannounced audits are part of the certification and the Notified Body's department.

As a Technical File Reviewer in our department, you will review medical-technical documentation from our customers within the medical device industry. Our customers are primarily based in Sweden, but we do also work with other parts of the world. Review of documentation is carried out according to a specific process, including writing reports mainly in English.

We are currently expanding our area and therefore looking for a number of Technical File Reviewers. Today we are 12 employees eager to optimise our processes, work more efficiently and expand our knowledge and competencies.

As a Technical File Reviewed you can expect to interact, on a frequent basis, with internal and external personnel including our customers, other members of the Notified Body team and management.

The role is permanent and based in Stockholm or Gothenburg.

Requirements:
At least 3 years’ experience in auditing, quality management, regulatory affairs, research & development or production/service. Experience in one or more of the following is a distinct advantage:

• Medical-technical industry
• Electrical, sterile, dental or implantable devices
• Software
• Health care
• Risk management
• Scientific literature or clinical trials
• Medical device regulations
• Auditing
• Industry practice and standards


Education:
Higher education and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors.

Personal competencies:
As a person you are independent, organised, analytical, thorough and results-oriented. You have a keen eye for detail but can also take a step back to see the bigger picture when required. Being focussed on delivering accurate and robust assessments within agreed timeframes is essential to the role.

Lastly, you have good working knowledge of Office systems, and speak and write Swedish and English fluently.

Intertek is a safe workplace with collective agreements, benefit package with pension, health care contributions and parental leave allowance. We have flexible working hours and encourage a good working climate and happy employees.

If you want to be part of our journey, we would love to hear from you!

Should you have any questions you are welcome to contact Joacim Jonasson, 08-555 651 26. 

Please send your application consisting of a CV and personalised cover letter to joacim.jonasson@poolia.se by 31.Jan.2017.