Regulatory Affairs Specialist

Mölnlycke Health Care

Presentation
For our client Mölnlycke Health Care we are looking for a Regulatory Affairs Specialist for a consultant assignment for four months that will start in February.

Pleasy apply today as selections and interviews are held on an ongoing basis.

Arbetsuppgifter
As a Regulatory Affairs Specialist you will implement actions in accordance with regulatory strategies and based on the input from regional directors. You will interact with R&D / business teams to secure the product approval and completion of the design control process and create understanding of primarily regulatory requirements.

Youre main responsibilities involve:

- perform training in regulatory related topics
- monitor and implement new regulation and changes in existing regulation
- consult with regional regulatory directors
- serve as regulatory affairs representative
- review and approve documents
- liaise with medical-vigilance associate regarding customer complaints
- keep the directors abreast of planned and performed activities

Utbildning/erfarenhet
You have a Univeristy degree, preferably in life science or material science, at least at a B. Sc. level. Additionally you have at least 5 years experience from work in a medical device company or at least 2 years experience in Regulatory affairs. You have experience from an international environment and have excellent english skills. Experience from IVD (in vitro diagnostics) is an advantage.

As a person you are used to communicate and network with scientific and regulatory personnel to obtain relevant information. You can assess and interpret regulatory requirements and their impact as well as negotiate internally and externally with regulatory agencies. You are used to apply risk-benefit analysis techniques and to write, review and prepare complex documents.

Please send your CV in english.

Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning
Poolia Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.