![Austin Vita](https://media.trabajo.org/img/noimg.jpg)
Senior Regulatory Affairs Specialist
1 week ago
Responsibilities:
Manage regulatory affairs objectives set by the SLT to meet the company’s Strategic Plan
To take the lead in all matters relating to regulation and applicable legislation
Development, management and maintenance of the company’s Technical Files and Design Dossiers
Responsible for the maintenance of Product Schedules with device classifications and allocating new GMDN codes.
Lead the Regulatory Affairs Team in new country product application to market including country specific technical report generation and submission.
Administer regulatory aspects of new product development initiatives and notify applicable changes to the Notified Body
Liaise with the company’s notified body / competent authority and oversee international submission processes. Host Notified Body Technical File audits.
Provide regulatory advice to other departments and Project Teams as and when required.
Skills/Experience:
Degree educated or equivalent in a life science or engineering discipline. A Member of the Organisation of Regulatory Professionals (MTOPRA)
At least five years’ experience in a life science regulatory environment ideally working with Class III Devices.
An in-depth knowledge of the international regulatory requirements for placing medical devices in UK, EU, North America, South America, the Baltics and AsiaPacific markets.
An in-depth knowledge of Management Systems in particular ISO 9001, ISO13485, RDC 59/2000, ISO 14001, OHSAS 18001, 21 CFR Part 820 & Part 11
Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales. Ability to write detailed reports.
Strong leadership and influencing skills
Capable of working on own initiative as well as leading successful cross functional teams. For immediate consideration please forward your most up to date CV
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Check us out on our and for more roles.
We respect your personal data and would never offer it to third parties For more information on how we handle your data, feel free to check out the or contact (url removed) Austin Fraser International Ltd is registered in England: (phone number removed) Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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