Senior Specialist Regulatory Affairs på SHL Group Medical
SHL Group Medical / Säljarjobb / Nacka
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SHL Group Medical designs and manufactures advanced products for injection and inhalation of drugs and is the world's leading supplier of auto injectors. With headquarters in Taiwan and sites in Sweden, USA and Switzerland, SHL Group Medical serves the world's largest pharmaceutical and biotechnology companies. SHL Group Medical was founded in 1989 and now employs more than 3600 worldwide.
Would you like to develop long term as part of a growth company, which continuously strengthens its position through innovative products? Then this is the position for you!
SHL GROUP MEDICAL OFFERS YOU A POSITION IN A DYNAMIC ENVIRONMENT WHERE WE DEVELOP AND MANUFACTURE PRODUCTS THAT IMPROVE PEOPLE'S HEALTH AND QUALITY OF LIFE. AS AN EMPLOYEE YOU TAKE A GREAT RESPONSIBILITY AND JOIN A GLOBAL ORGANIZATION AT AN EXPANDING STAGE. WE ARE NOW SEEKING A SENIOR SPECIALIST REGULATORY AFFAIRS FOR OUR OFFICE IN NACKA STRAND.
TO THE POSITION AS SENIOR SPECIALIST REGULATORY AFFAIRS, WE WISH TO EMPLOY SOMEONE WITH THE KNOWLEDGE, EXPERIENCE AND INTEREST OF/IN THE FOLLOWING DUTIES AND RESPONSIBILITIES:
- ACTS AS COMPANY LIAISON WITH REGULATORY HEALTH AUTHORITIES. DEVELOP REGULATORY STRATEGIC PLANS SPECIFIC TO DEVELOPMENT PROGRAMS.
- LEAD AND AUTHOR DELIVERY OF REGULATORY SUBMISSION DOSSIERS. DRIVE AND IMPLEMENT PROCESS AND SYSTEM IMPROVEMENTS TO ENSURE SUCCESSFUL SUBMISSION OUTCOMES.
- ENSURE APPLICABLE REGULATIONS AND STANDARDS ARE INTEGRATED WITHIN THE ORGANIZATION BY E.G PARTICIPATE IN STANDARDIZATION ORGANIZATIONS.
- GUIDE THE ORGANIZATION INCLUDING MANAGEMENT TEAMS TO ENSURE THAT SHL COMPLIES WITH UP-TO-DATE REGULATIONS AND STANDARDS PERTAINING MEDICAL DEVICE AND OTHER PRODUCTS OR SERVICES FOR E.G ISO 13485 AND ISO 9001 PRODUCTS.
- MANAGEMENT OF SHL'S CERTIFICATES, AUTHORIZATIONS, DEVICE REGISTRATION ETC.
- PROVIDE INPUT FOR REGULATORY REQUIREMENTS AND REGULATORY STRATEGIES IN INTERDEPARTMENTAL MEETINGS ON PRODUCT DEVELOPMENT TO ENSURE TIMELY SUBMISSION AND APPROVAL.
- ESTABLISHING REGULATORY SUBMISSION PLAN, WHEN APPLICABLE.
- ESTABLISHING AND APPROVAL OF ESSENTIAL REQUIREMENT CHECK LIST, WHEN APPLICABLE.
- ESTABLISHING AND APPROVAL OF DOC WHEN APPLICABLE.
- ACTING AS COORDINATOR AND/OR SINGLE CONTACT POINT < SHL-CUSTOMER/AUTHORITY > IN SUBMISSION PROCESS.
- TO PARTICIPATE IN DESIGN REVIEWS AS RA SUBJECT MATTER EXPERT.
- PROVIDE GUIDANCE TO ALL APPROPRIATE DEPARTMENTS IN SHL TO ASSURE COMPLIANCE WITH APPLICABLE REGULATIONS
- DIRECTLY INVOLVED IN THE PREPARATION, ASSEMBLY AND SUBMISSION OF ALL GLOBAL REGULATORY DOCUMENTS, SUCH AS MAF, CTD AND OTHER INTERNATIONAL REGULATORY SUBMISSIONS IN VARIOUS COUNTRIES.
WOULD YOU LIKE TO KNOW MORE?
For further information, please visit our website
www.shl-group.comIf you have any questions regarding the position, feel free to contact Andrea Josefsson, HR, by emailing
andrea.josefsson@shl-group.comPubliceringsdatum2018-03-21Övrig information• Rekrytering sker löpande
Kvalifikationer• Do you have a Bachelor's degree
• Do you have at least 3 years of experience in Regulatory Affairs?
• Do you have experience from FDA and EU product registrations?
• Do you have experience from second and third party audits?
Varaktighet, arbetstid
Heltid Tillsvidare
ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2018-04-18
Klicka på denna länk för att göra din ansökanKontaktSHL Group Medical
FöretagSHL Group Medical
AdressSHL Group Medical
Augustendalsvägen 7
13152 Nacka
KontorsadressAugustendalsvägen 7, Nacka Strand
Jobbnummer 4037040
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