Specialist Regulatory Affairs
SHL Medical AB / Administratörsjobb / Nacka
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Visa alla administratörsjobb i Nacka,
Kristinehamn,
Karlskoga,
Storfors,
Lekeberg eller i
hela Sverige Visa alla jobb hos SHL Medical AB i Nacka SHL Medical AB, part of SHL Medical, offers you a position in a dynamic environment where we develop and manufacture products that improve people's health and quality of life. We are now looking for a Specialist Regulatory Affairs for our office in Nacka Strand, Stockholm.
As a Specialist within Regulatory Affairs, you will be part of a team of 3 highly skilled specialists in Nacka Strand, and many more globally. Main focus will be to contribute to and support various development projects, throughout the product life cycle. This means interacting with most functions and departments at SHL Medical AB, such as Product Development, Project Management and Quality Assurance. You will also be in contact with and provide support to customers and their RA representatives, as well as internally with our SHL colleagues in Taiwan, US and Switzerland.
As a Specialist Regulatory Affairs, you carry out various work tasks, for example:
Act 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.
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.
Acting as coordinator and/or single contact point < SHL-Customer/Authority > in submission process.
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.
We see that you have a background within QARA, and that you have a MsC or corresponding work experience. You are fluent in English, in speech and writing. We highly value experience within the medical device field. You have strong communication skills and have the will and ability to work and collaborate in a global company.
Would you like to know more? Please visit our website or follow us on LinkedIn.
We welcome your application!
Så ansöker du Sista dag att ansöka är 2023-05-14
E-post:
RecruitSE@shl-group.com Omfattning Detta är ett heltidsjobb.
Arbetsgivare SHL Medical AB (org.nr 556530-9696),
https://www.shl-medical.com/ Augustendalsvägen 19 (
visa karta)
131 52 NACKA STRAND
Jobbnummer 7733296
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