Job title: Regulatory Manager IVD Scotland 50k

Job description:
RA Manager / Regulatory Manager / Reg Affairs Manager / Regulatory Affairs ManagerRegulatory Affairs Manufacturing Manager (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. Accountabilities-Strategize and prepare regulatory filings such asIDE,PMA and Design Dossier submissions and subsequent revisions/supplements and amendments.- Represent regulatory function on project teams on a regular basis and provide input into regulatory strategies for various projects- Provides guidance on regulatory environment, compliance practices, and enforcement strategies- Manage and execute regulatory submissions- Prepare presentations to FDA reviewers and/or inspectors as needed- Review and approve Product Incident and MDR reports- Review and approve Documents Change Order requests, CAPA's, NCR's, etc.- Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOP's and protocols- Strategize and prepare international product registrations and licensing documentation..- Manage various integration and Cardinal related project plans.- Maintain information in various compliance databases and produce reports as needed- Manage the maintenance of a well-organized filing system of all regulatory files- Perform internal and supplier audits as needed. Qualifications- Bachelor's degree in a related field and 8 years experience in health-care related industries (hospitals, labs, pharma, IVD or devices), including previous Regulatory Affairs experience and 3 or more years experience in the medical device industry.- Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings- Experience in direct communication with regulatory agencies- Experience with international regulatory filings a plus- An advanced degree is desirable. In Vitro Daignostic / Biologic experience would be a plus- Excellent written and oral communication skills; technical writing capabilities are a must- A hands-on, decisive, action-oriented style must be evident What is expected of you and others at this level- Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects- Participates in the development of policies and procedures to achieve specific goals- Recommends new practices, processes, metrics, or models- Works on or may lead complex projects of large scope- Projects may have significant and long-term impact- Provides solutions which may set precedent- Independently determines method for completion of new projects- Receives guidance on overall project objectives- Acts as a mentor to less experienced colleaguesFor more information, please click 'apply' to send an up to date copy or your CV or alternitively, contact Marvin Trenchfield at Real Life Sciences.0207 758 7311https://uk.linkedin.com/in/marvin-trenchfield-980686b7

Employer Name: Choobah Limited

Job short description: Training and staff development professionals

Country: United Kingdom

Region: Clackmannanshire and Fife

Contract duration: Permanent

Contract type: Full time

Source of job offer:
Department for Work and Pensions, Public Employment Services, United Kingdom

How to apply: Other - see free text

Salary currency: GBP

Salary period: Annually