id: NDkxODA1MiA3

reference: 4918052

documentId: 4918052

connectionPointId: 7

lastModificationDate: 1544697963260

stillingsbetegnelse: Regulatory Affairs Assistant

jobbeskrivelse:

 

We are a global company operating within the IVF medical field, providing various solutions for the In Vitro Fertilization laboratories. We own one of the most known and widely recognized brands on the market, influencing fertility processes and pregnancy rates around the globe. Our team is engaged to ensure top quality products and fast supply every day. Are you ready to join one of the world’s most famous companies within IVF solutions? We are looking for a Regulatory Affairs Assistant. You will ensure that everything is in order according to instructions, guidelines, and regulations.

The job: 

You will be a part of the Regulatory Affairs department, and you will be responsible for ensuring compliance with new and updated regulatory requirements and controlling product’s technical file. In addition, the team is involved into broad communication with the company's distributors.

Our job requirements are:

• good research and data analysis skills
• ability to multitask and prioritize
• understanding quality management system principles
• knowledge of Medical Device Directive 93/42/EEC
• knowledge of CE marking process (experience is an advantage)

Your main responsibilities will be:

• Maintaining technical documentation;
• Researching and supporting distributors with various issues related to the company’s product;
• Assuring product compliance with relevant regulatory requirements (medical device, biocides);
• Supporting other departments when needed.

 
Qualifications and experience:

 

The Bachelor’s or Master’s degree in science or engineering field. It is an advantage to have work experience within the medical device sector, e.g. from direct employment, internship, graduate program, or consultancy.

You have an analytical mind-set and systematic approach to your work. You are a team-player and like to be challenged. Ability to communicate with people with different backgrounds and work positions is necessary for this position. Excellent communication skills in written and spoken English are required.

 

Working at SparMED: 

The commitment and ambition of our employees help us to successfully operate within the In Vitro Fertilization field influencing pregnancy rates around the globe. In return we offer:

 

- A wide range of opportunities for professional development through training courses, exhibitions, IVF annual meetings etc.

- An informal international work-environment

- Flexible working hours

- Extra vacation days

- Sick, personal, and parental leave

- Health insurance

- Retirement plan

 

Contact:
For further information, please contact Agnes Bugno at agnes (at) sparmed.dk.

 

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2149

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: SPARMED ApS

source: DK-STAR