Pharm Assist Sweden AB is a professional service company offering quality assurance and regulatory affairs solutions for medicinal products and medical devices. Founded in 1996 the company has assisted more than 250 pharmaceutical and medtech companies over the years. Pharm Assist’s highly qualified team of some twenty five professional consultants has a strong scientific, business and regulatory experience and puts pride in providing tailor-made professional solutions for its clients.

Pharm Assist’s services range from regulatory strategy, product registrations and product life cycle management, pharmacovigilance and post-market surveillance, medical and regulatory writing, good distribution practice in the field of medicinal products, to support in development of quality management systems based on ISO 9001 and ISO 13485, risk analysis using ISO 14791, to regulatory support ensuring MDR and/or IVDR compliance for medical devices and in vitro diagnostics including medical device software.

Our geographic focus is the Nordic countries. However, we work with clients and projects in many international markets as well. through a well-proven and validated network of partners within regulatory affairs, clinical trials/investigations, medical writing, translations and health economics.

Pharm Assist is located less than 5 minutes’ walk from Uppsala railway station, close to the Swedish Medical Products Agency and the two prominent universities of Uppsala. The Uppsala/Stockholm region has many pharmaceutical and medical technology companies which serve as the client base, as well as a source of employees.

Our goal is to help the pharmaceutical and medical device industry to develop, manufacture and sell safe medicines and medical devices, and to make the world healthier and safer.

 

QA/RA Medical Devices konsult

Tjänsten: QA/RA Medical Devices konsult
Placering: Uppsala


Opportunities with the role
You will be part of a fast-growing and successful consulting and service company that offers regulatory solutions for medical and Medtech products. A company that cares that employees have a good balance between work and private life.
Pharm Assist Swedan AB is a company where you feel welcome and the atmosphere is very pleasant.
Present and engaging leadership where you get the opportunity to take great responsibility, work independently and be innovative and solution-oriented.
Highly values ​​personal development. Leadership role opportunity.

Profile
You are service-oriented, self-sufficient and can easily and fluently express yourself in English and Swedish, written and spoken. You are detailed-oriented, structured and can prioritize, while still maintaining a pragmatic approach. You are used to manage time effectively. Experience from the life science industry and/or from interacting with the Medical Products Agency is a prerequisite. At Pharm Assist you would add value to the team based on your experience, personality and be a critical member to make sure that the med tech business develops, deliver and grow at a high and healthy pace.
It is an advantage if you have experience from leading and inspiring people. You may be considered as part of the management team and as a leader of a group of 5-10 people within 12 months.

Qualifications
• M.Sc., PhD or similar life science education;
• Minimum 5-10 years of experience from the life science industry, as regulatory affairs consultant or the Medical Products Agency;
• Trained and familiar with Swedish and European regulations relating to MDD, IVDD, MDR and IVDR;
• Trained and familiar with ISO 13485:2016, ISO14971:2012, etc,
• Prepared to travel 30-40 days per year;
• Speak and write Swedish fluently
• Speak and write English fluently.
• Qualifies as PRRC (Person Responsible for Regulatory Compliance) according to MDR/IVDR.

Merits
• Experience from working as consultant and service provider;
• Experience from the diagnostic industry and software as medical device;
• Experience from working at a Notified Body;
• Experience from sterile medical devices;'
• Experience from US regulations or other international legislations
• More than 5 years of experience from medical device industry within the field of regulatory affairs, life cycle management, post market surveillance, etc;
• Experience from regulatory affairs matters such as clinical trials/investigations, usability, medical writing, etc;
• Interested in the commercial aspects of being a professional service provider; and
• Experience from leading trainings and performing presentations.

For inquires and more information about the position, please contact Malin Hammarling, Recruitment Consultant at PeakSearch.

E-mail: malin.hammarling@peaksearch.se

Mobile: +46 (0)70-235 81 99