Regulatory Affairs Manager
Natumin Pharma AB / Apotekarjobb / Habo
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hela Sverige This position offers you a great opportunity to work cross-functional, locally and globally, with a wide variety of
people inside a growing organization. It is an excellent chance for a talented and dedicated regulatory affairs
professional to take part in improving world class products in a challenging regulatory environment with high
ambitions within a global and fast-paced manufacturing organization.
Position
As a Regulatory Affairs Manager you will be a member of the QA/RA team for the product areas Medical device,
Cosmetics and Food supplements towards internal and external customers.
Main Responsibilities
Establish and keeping up-to-date product documentations for our medical devices, cosmetics and
food supplements.
• Develop and submit applications to various countries for market clearance/approval
• Support the distributors when those are applying for new or updated regulatory approvals
• Support the sales units
• Support the R&D and market introduction projects
• Support Product Maintenance
• Communicate with authorities, notified body and other external actors
The position is located at our site in Habo and you will be reporting to the Quality Manager. Occasional international
travel may be required.
The ideal candidate
As ideal for the position you have at least three years' experience within QA/RA from the medical device industry or cosmetics/food supplement. Experience from regulations and standards, such as MDD, ISO13485 and QSR, cosmetics and food supplement regulations, as well as knowledge in standards for risk management for medical devices is beneficial. Further, you have a Master degree in a relevant field together with fluent proficiency in Swedish as well as in English.
As a person you are action-orientated, driven and independent with a great amount of integrity. You have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and collaborate with both internal and external partners. An ability to work in a changing environment is also a key factor for this position. The success criteria will be your ability to communicate with and engage your stakeholders in ensuring that your projects and activities are executed on time and where you have identified all risks and opportunities associated here with.
We expect that you present yourself as a person who takes individual responsibility and has a positive attitude towards your work and others. You demonstrate excellent communication skills both verbally as well as in writing. You are able to go into depth with analyses and detect the risks associated with your projects. You also take great pride and ownership in your projects, and are comfortable having a lot of room to navigate.
Natumin Pharma is a company that focuses on the development of unique products based on innovative ingredients in combination with extensive research.
Medica Nord is a sales and marketing company with distribution throughout Sweden and Norway and also exports products to over 10 countries outside the Nordic region. The products are in the categories of food supplements, Traditional Herbal Medicinal Products, Medical Devices, cosmeceuticals and a wide range of skin care products. The company was started in 2006 and the group has a turnover in the region of 120 million SEK, showing growth and profitability. Natumin Pharma is within the Medica Nord family.
Publiceringsdatum2017-08-11Så ansöker duSista dag att ansöka är 2017-09-10
Ange följande referens när du ansöker: Regulatory Affairs Manager
KontaktJennie Sandström
jennie.sandstrom@natumin.seFöretagNatumin Pharma AB
AdressNatumin Pharma AB
Snickaregatan 10
56633 Habo
KontorsadressSnickaregatan 10
Jobbnummer 3639051
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