Senior Regulatory Specialist for SHL Group
Dfind Science & Engineering AB / Kemiingenjörsjobb / Stockholm
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Are you a specialist in regulatory submissions with a penchant for interacting with both customers and Health Authorities?
SHL Group offers a role in a highly skilled RA team, responsible for product and process compliance and coordination of product submissions in a growing company. The team is distributed among three sites (in Sweden, US and Taiwan), and the role as Senior Regulatory Specialist is global with primary location in Stockholm. You are expected to do some travelling between the sites and to act as the company interface towards health authorities.
The work tasks are both project related and system related, and includes:
• Actively support regulatory compliance and ensure compliance of submission to regulatory agencies.
• Prepare supportive documentation for regulatory deliverables, research trends in regulatory and respond to regulatory questions.
• Provide primary authorship to routine regulatory correspondence. Support the development and execution of regulatory team goals.
• Supporting project teams to establish Design History File (DHF).
• Establishing submission plans.
• Creating submission/registration dossiers.
• Requirement management.
• Management of company certificates, authorizations, registrations etc.
Qualifications and experience
• Bachelor in Engineering or Science.
• 5 years of experience in Regulatory Affairs.
• Knowledge of FDA's QSR, GMP's, CMDR, Medical Device Directive 93/42/EEC, Combination Product 21CFR Part 4 and ISO standards including ISO 13485, 10993 and 14971.
• Experience from second and third party audits.
• Experience from FDA and EU product registrations.
You are very communicative and speak fluent English, both orally and in writing. You possess a high level of analytical thinking and integrity and thrive from structure and order. You enjoy working in a global role.
Is this you? Send us your application as soon as possible.
Employer: SHL Group
Placement: Stockholm
Working hours: Full time (40 hrs/week)
Last application day: March 12, 2017.
Application and information: In this recruitment process SHL Group collaborates with Dfind Science & Engineering. Please apply at
www.dfind.se/science-engineering. Resume and personal letter is required in English.
Contact: Jenny Davidsson, Dfind Science & Engineering, +46 (0)70 544 82 38 or Åsa Vallin, Dfind Science & Engineering, +46 (0)73 343 40 45
About SHL Group
SHL Group designs and manufactures advanced products for injection and inhalation drugs and is the world's leading supplier of auto injectors. With headquarters in Taiwan and sites in China, Sweden and USA, SHL Group serves the world's largest pharmaceutical and biotechnology companies. The SHL Group was founded in 1989 and now employs more than 3 200 worldwide. SHL Group AB serves as the Design Office for the group and employs around 100 people in Nacka Strand.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-02-21ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-03-12
Ange följande referens när du ansöker: 201027387
Klicka på denna länk för att göra din ansökanKontaktJenny Davidsson
jenny.davidsson@dfind.se +46705448238
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3333460
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