Associate Director Medical Devices & Combination Products
AstraZeneca Göteborg / Sjukhusteknikerjobb / Mölndal
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The Regulatory Affairs CMC (Chemistry, Manufacturing & Control) group sits within the AZ Global Regulatory Affairs, Patient Safety and Quality Assurance (GRAPSQA) organisation and is accountable for delivering CMC regulatory strategy as well as operational and tactical expertise for projects throughout the product lifecycle.
We are now looking for an experienced Associate Director (AD) to join our Regulatory CMC team in Gothenburg, Sweden. As AD you will be responsible for providing device related regulatory expertise, guidance and input to medical device and combination product projects. These systems may incorporate electronic and software technology. This position will require significant interaction within research and development functions particularly working with the Device Technical teams in Pharmaceutical Technology & Development, as well as collaborating with AstraZeneca's manufacturing and quality organizations. This individual must be able to effectively work in a matrix environment and drive consensus on 'best answer' for complex scientific and product initiatives.
Key accountabilities will include;
Advising product development teams on device related regulatory aspects of medical device & combination product projects including (but not limited to) those involving drug delivery devices and companion software-based devices
Reviewing and contribute to medical device & combination product regulatory submissions and documentation (INDs, CTAs, BLAs, MAAs, 510(k)s, Technical Files etc...)
Supporting preparation for meetings with regulatory agencies and attend as required
Supporting the development and implementation of guidance and requirements for regulatory strategies for medical devices & combination products
Supporting development and integration of regulatory processes for medical device/combination product development and commercialisation interfaces
Advising on and support medical device/software/combination product regulatory compliance initiatives
Supporting the development and integration of connected delivery devices and app/software-based companion platforms
Supporting AZ device related networks
Supporting and coach peers within AZ
Representing AZ at external events (PhRMA, PDA, ISPE, BIO, DIA, IPAC-RS, AAMI/ISO, etc.), as required
Minimum Requirements:
BS/MS in a Regulatory Affairs, Life Sciences, Engineering or related field.
Proven experience in regulatory affairs with a focus on combination products and medical devices (including knowledge of electronic/software-based devices). Other relevant experience in the biopharmaceutical industry considered.
Significant experience in the combination product or medical device industry
Demonstrated experience in Regulatory Affairs [e.g. IDE/510(k)/PMA filings; application of device quality management system, software validation, human factors, and design verification/validation requirements]
International Regulatory Affairs experience e.g. CE marking, technical file/design dossiers, application of international device standards (eg, ISO 14971, ISO 13485, ISO 60601, IEC 62304) and medical device and/or combination product regulations
Strong understanding of regulations governing marketing of medical device & combination products.
About AstraZeneca:
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Publiceringsdatum2019-03-15Så ansöker duSista dag att ansöka är 2019-03-29
FöretagAstraZeneca Göteborg
KontorsadressPEPPAREDSLEDEN 1
Jobbnummer 4671041
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