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reference: 4896078

documentId: 4896078

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lastModificationDate: 1540462866346

stillingsbetegnelse: Regulatory Affairs Manager, Denmark

jobbeskrivelse:

Regulatory Affairs Manager

Would you like to use your skills and knowledge of management and regulatory affairs processes to manage an international team of highly qualified regulatory affairs specialists? Then we have a great opportunity for you.

Interacoustics is a leading supplier of premium brand diagnostic equipment used every day in clinics and hospitals around the world. We design, manufacture and sell products across the entire audiological spectrum, from small portable devices to full clinical instruments.

From our headquarters in Middelfart, Denmark, we sell our equipment in more than 100 countries through our own sales companies and external distributors.

The job
With reference to the Director, Regulatory & Compliance, you will be leading the registration team responsible for the registration of our products in the markets we operate. Our team consists of six persons, three in Poland and three in Denmark.

In your new role, you will be in close contact with the Sales, R&D and Product Management functions in the companies in the Diagnostic Division. The division consists of several individual brands, including Interacoustics, placed in Denmark, UK, USA and Germany. Your role requires a close collaboration with these brand and their local representatives in the markets where we register and sell our products.

Your main responsibilities will be:

• Management of the multi-site Regulatory Affairs team.
• Support and challenge our business managers in Diagnostic Division as well as distributors worldwide in questions regarding product registrations.
• Ensure a structured approach to product registration.
• Identifying and communicating the regulatory requirements for relevant countries.
• Monitoring regulatory changes and assessing their impact.

We offer an exciting job opportunity in an international company with varying tasks and plenty of possibilities to influence your daily work. The work environment is informal and you will find your colleagues dedicated to their work where an open and honest atmosphere contributes to mutual development and learning.

Personal qualifications
We expect you to hold a degree in Science at B.Sc. or M.Sc. level but more importantly, you are a skilled Regulatory Affairs Manager preferably with 3-5 years of experience in managing registration teams within the medical device or pharmaceutical industry.

As a person, you are an outgoing, self-managed and curious team player, who can create and maintain good relations with stakeholders. You have a high drive and a positive attitude towards things. You are extremely flexible and adaptable and still characterized by a structured, analytical and disciplined work approach. As you will collaborate with many different nationalities, it is important that you are able to communicate clearly and have a cultural understanding. Furthermore, you have a systematic approach to your work combined with a sense for details.

We expect you to be fluent in English, both written and spoken, as you will be communicating with our global colleagues and collaborators on a daily base.

Do you want to join the team or learn more about the position?
Then upload your CV and cover letter as soon as possible. We are continuously conducting interviews.

For more information about the position please contact Director, Regulatory & Compliance, Erik Nielsen on +45 2223 0834.

Interacoustics

Interacoustics is a world leading diagnostic solutions provider in the field of hearing and balance assessment. We design, manufacture and sell products across the whole audiological spectrum, from small portable devices to full clinical instruments. Our products are sold in more than 100 countries through our extensive network of sales companies and distributors. 

Interacoustics employs more than 150 people at the head office in Middelfart, more than 500 worldwide and is among the world's leading suppliers of audiological equipment.

Interacoustics is part of the William Demant Holding Group. This group of international companies develops, manufactures and markets a wide variety of technological solutions, ranging from state-of-the art digital hearing instruments and assistive listening devices to revolutionary new diagnostic systems.

For more information, please go to:  http://www.interacoustics.com.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1321

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: INTERACOUSTICS A/S

source: DK-STAR