Inhalation Sciences Sweden AB
Inhalation Sciences Sweden AB (publ) utvecklar och kommersialiserar världsledande instrument för forskning inom inhalation. Bolagets patenterade labinstrument, PreciseInhale erbjuder forskare möjligheten att, med mycket hög precision, karakterisera hur aerosoler och små partiklar påverkar våra lungor när vi andas in dem. PreciseInhale är ett tekniskt avancerat laboratoriesystem för noggranna mätningar av hur partiklar i inandningsluft påverkar våra lungor och därmed vår hälsa. Dagens etablerade metoder bygger på teknologi från 1950-talet som ger stor variation i mätningarna och låg korrelation mellan laboratoriemiljö och kliniska tester. Genom en serie verktyg, eller moduler, kan PreciseInhale anpassas utifrån kundens specifika behov och med bevisad stor överensstämmelse mellan laboratoriemiljö och klinisk användning korta ned utvecklingstid och kostnad för nya läkemedel.
För mer information kring denna innovativa produkt, gå gärna in och läs på: http://www.preciseinhale.com/
Företaget är noterat på Spotlight och befinner sig nu i en expansiv och mycket spännande fas. Idag har bolaget 7 heltidsanställda och 6 konsulter, med avsikt att växa. För mer information gå gärna in på företagets hemsida: http://www.inhalation.se
Quality- and Regulatory Affairs Manager
Job Title: Quality- and Regulatory Affairs Manager
Reports to: CEO
Location: Huddinge, Stockholm
Inhalation Sciences Sweden AB is a small, listed and growing medtech company in Stockholm. They now seeks to appoint a person with a solid and documented experience of regulatory and QA issues including submission to authorities of medtech products in different markets (particularly in Europe and USA). The Quality- and Regulatory Affairs Manager shall assure quality on products and processes by establishing and enforcing quality standards within the entire company.
This pivotal role at the company requires a professional individual with international RA&QA experience, preferable from a small/medium size company engaged in product development. The position reports to the CEO and is based at the office in Huddinge.
The Quality- and Regulatory Affairs Manager will manage the activities of ensuring the implementation of appropriate and effective regulatory strategies regards to product development. The appropriate person shall manage and oversee all maintenance activities for existing and coming CE-labelled products and align the Life cycle Management strategy accordingly. You expect to provide expert Regulatory and QA input to strategic decisions including portfolio review, prioritization and external communication. Documented experience and a high knowledge in ISO-13485, 9000 and FDA requirements in USA is a must.
Qualifications
• A solid and documented experience of regulatory and QA issues including submission to authorities of medtech products in different markets (particularly in Europe and USA)
• Documented experience and a high knowledge in ISO-13485, 9000 and FDA requirements in USA is a must
• Fluent in Swedish and English, oral and written
• Experience of working for a listed company is a merit
• Experience and an understanding of what it means to work in smaller companies with strong development potential is an advantage
Personal characteristics
• Ability to plan, prioritize and implement activities according to established goals
• Following, and ability to create procedures and policies
• Strong communication skills
• Team player, being able to operate successfully across all levels in the organization
• Good interpersonal skills
• Confident and self-dependent with the ability to work both independently as well as working in a team
• Manages knowledge (collects, classifies and disseminates knowledge of use to the organization)
• Positive “can-do” attitude
• Proactive
Opportunities with the role
• To work with a broad spectrum of responsibilities in a small listed medtech company and to contribute to the growth of the company
• This is a key position at the company with the great opportunity to build, lead and develop the quality- and regulatory initiatives for the company to secure success in the future
• Work for a company where results and benefits go hand in hand and where you truly can bring your potential into play
Contact
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details:
Marta Frick marta.frick@peaksearch.se Tel: 070-386 89 69