Senior Regulatory Affairs and Quality Assurance/Responsible Person

H&P Search & Interim AB is a company with substantial experience in recruitment (Search) as well as placing consultants (Interim). Our focus is 100 percent on Life Sciences in the Nordic region: pharmaceuticals, biotechnology, medical technology, and related industries. We have a broad network of contacts and a keen awareness of changes in the market.  Our employees themselves have medical, natural science and economic backgrounds, as well as great experience in leadership at all levels. H&P Search & Interim are specialists in recruitment (Search) and placing consultants (Interim) at all levels and areas within a company.  We help clients to find the right co-workers and consultants within, e.g. sales and marketing; market access; medical, clinical, quality assurance and regulatory affairs; logistics and distribution. For further information, please see www.hpsearch.se

 

 Are you a regulatory and quality assurance expert in pharma/drug development and/or medical technology products? Would you be interested in working as a Consultant but also supporting the further buildup of our own regulatory affairs and quality assurance team?

Then maybe you are the one we are looking for as:

Senior Regulatory Affairs and Quality Assurance/Responsible Person

 

H&P Search & Interim is now looking to employ a Senior Regulatory Affairs and Quality Assurance/Responsible Person to be employed by H&P Search & Interim. This is for us to further extend and expand our services to our Pharma and Medtech clients. Today, H&P Search & Interim has several senior Quality Assurance staff employed and we now look to increase capacity also in Regulatory Affairs with this combined role. This is a permanent position, and you will be working from any of our offices in Stockholm or Uppsala or at the client’s office in Stockholm/Mälardalen. You report to one of the partners at H&P Search & Interim and have the chance to be a part of dynamic company where you will work in RA/QA-team with opportunities to influence and contribute with your ideas and experience.

 

The position:

In a complex world positions like this tend to be just like that – Complex! We therefore would like you to have as much as listed below as possible:

  • Extensive experience in Regulatory Affairs, GMP and GDP and wholesale activities, in order to be working for our Pharma Clients within Regulatory and Quality matters and as a responsible person (RP).
  • Detailed knowledge of the European approval system including European Medicines Agency (EMA).
  • Life cycle management and maintenance activities for products approved through Centralised Procedure, Mutual Recognition and National Procedures.
  • Experience within the MedTech areas such as ISO 13485 and FDA’ QSR as well as MDR 2017/745 and all other relevant standards.

 

Assignments:

  • Acting as Responsible Person for wholesales activities in Sweden, Norway and Denmark.
  • Review of company’s quality system and recommend improvements.
  • Acting as local PV contact person.
  • Maintenance work for head offices and local Nordic subsidiaries.
  • Price and reimbursement applications in the Nordic countries.
  • Audit of manufacturers and processes to GMP/GDP standards (e.g. sterilization plant, terminally sterilized product, device manufacturer, filter manufacturer, wholesaler).
  • Coordinating projects to implement the MDR 2017/745 and supporting relevant department in fulfilling regulatory requirements.
  • Managing technical documentation for new product development as well as revising already existing technical documentations.
  • Communicating with responsible regulatory authorities as well as with notified bodies.
  • Assuring conformity and regulatory compliance of technical documentation throughout product’s life cycle.
  • Training the organisation on the topic of regulatory affairs.
  • Staying informed about any changes in relevant legislation etc.
  • Producing quality documentation and carrying out product quality reviews and performing audits to ensure that all devices comply with regulatory requirements.
  • Responsible for conducting internal audits and hosting external audits.
  • Ensure quality system is implemented and maintained.
  • Accountable for decision for recall.
  • Ensuring customer complaints are dealt with effectively.
  • Ensure suppliers and customers are approved.

 

Who are you?

For this role we are looking for a candidate with university degree in Pharmaceutical Science (or equivalent) with at least 7 years’ of experience from working in a combined RA/QA-position in Pharmaceutical industry as this is a senior role. To be considered for the position your quality and technical experience need to meet local HA´s Medicine’s Agency requirements for “Responsible Person”. It would be a strong merit if you have experience of managing and audit external GMP/GDP suppliers. The role requires good knowledge or experience from medical technology standards and regulations such as ISO 13485, MDD / MDR. International experience is an advantage. If you have previous experience from an authority or solid knowledge within CMC, this is also considered a merit. This position requires ability to work independently and sometimes make sound and effective quality decisions under pressure. To be effective you will also need good social skills as you will have many internal and external interactions. You need to be fluent in Swedish and English (oral & written).

 

Next steps:

If this sounds interesting to you, contact one of us below for more information. Alternatively, you can apply directly by uploading your resume and by emailing us a line. Please note: Only applications in English will be considered and the expected starting date for this position is as soon as possible.

We look forward to your application!

 

Ann-Katrin Broman                                                           Torbjörn Ströberg

Partner                                                                                Partner

A.Broman@hpsearch.se                                                  Torbjorn.Stroberg@hpsearch.se

+46 (0) 707 555 094                                                         +46 (0) 703 778 774