Technical support specialist Work, Jobs in Kirkliston, Edh (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Management
- Data analysis skills
- Leadership
Senior Application Support Consultant
Symology Ltd —Falkirk
- £28,000 - £32,000 a year
- Full-time
- Hybrid work
- Customer service
- Salesforce
- Communication skills
- Profit sharing
- Health & wellbeing programme
Quick apply
4d
Regional IT Support Specialist
Omexom UK —Scotland
- Customer service
- In-person
- Communication skills
Business Support Specialist
LRQA group —Inverleith
- Spanish
- English
Transformation PMO Analyst
Equans —North Lanarkshire
- Full-time
- Organisational skills
- Communication skills
- Annual leave
- Employee assistance programme
10d
Project Manager/Business Admin Apprentice
Sulzer —Falkirk
- Full-time
- English
- Project management
- Time management
Assistant Ecologist
WSP —Edinburgh
- Communication skills
Water Hygiene Risk Assessor - Scotland
HSL Compliance Limited —Wishaw
- £13.57 - £15.10 an hour
- Full-time
- Travel
- Communication skills
- Annual leave
- Sick pay
Quick apply
Global Logistics Specialist
Invinity Energy Systems —Bathgate
- Full-time
- Hybrid work
- Annual leave
Quick apply
8d
IT Support Specialist
Cirrus Logic —Edinburgh
- Full-time
- Customer service
- No degree
- IT
JLR Diagnostics Technician
BCA —Livingston
- £22 an hour
- Monday to Friday
- Driving
- Mentoring
- Automotive diagnostics
- Employee assistance programme
Quick apply
Support Administrator
Lane Clark & Peacock —Edinburgh
- Hybrid work
- Microsoft Excel
- Microsoft Office
- Organisational skills
- Annual leave
- Employee discount
3d
Electrical Field Engineer
United Infrastructure —Scotland
- Full-time
- AutoCAD
- Travel
- Communication skills
Quick apply
Senior Specialist, Regulatory & Technical Support, UK Trustee & Depositary
The Bank of New York Mellon Corporation —Edinburgh
- Full-time
- Analysis skills
- Communication skills
Biomedical Scientist - Annex21
NHS Scotland —Wishaw
- £43,231 - £52,679 a year
- Call to connect
- Bachelor's degree
- Annual leave
- Sick pay
12d
Audit Assistant Manager - Scotland
BDO —Edinburgh
- Full-time
- Supervising experience
Senior Information Security Specialist
Burges Salmon —Edinburgh
- Travel
5d
Design Coordinator
Wills Bos Civil Engineering Ltd —Holytown
- From £28,000 a year
- Full-time
- Civil engineering
- Electrical experience
- Organisational skills
- Free parking
- Health & wellbeing programme
Quick apply
4d
Product Support Specialist - Institutions
Opus 2 —Edinburgh
- £40,000 - £45,000 a year
- Full-time
- Hybrid work
- Product management
- Python
- Employee assistance programme
Quick apply
SMCR Risk Consultant
Standard Life —Edinburgh
- £43,500 - £65,000 a year
- Annual leave
3d

I want to receive the latest job alerts for technical support specialist in kirkliston, edh

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Department Leader, Regulatory Affairs

AliveDx -
Penicuik

Apply Now

Job details

Permanent | Full-time

Benefits

Cycle to work scheme

Qualifications

Management
Data analysis skills
Filing
Leadership
FDA regulations

Full job description

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

Department leader, REGULATORY AFFAIRS

We are recruiting for a Department Leader to join our Regulatory Affairs Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

The Department Leader for Regulatory Affairs is responsible for the initial registration of new products and for ensuring the continued registration for all Alba products after initial registration or approval, by liaising with regulatory bodies to address compliance issues and to provide this information to the appropriate staff groups.

JOB DESCRIPTION
The main responsibilities will include:

Serve as a member of the Regulatory and Quality Management Team for oversight and guidance of the entire organisation on RA and Quality strategy and activities
Ensure that technical documentation and the EU declaration of conformity of the devices for which Alba Bioscience Ltd is the legal manufacturer are drawn up and kept up to date
Manage, prepare and maintain regulatory documentation to enable the Company to comply with ISO13485 standard and to ensure regulatory compliance with the 98/79/EC IVD Directive (IVDD), Regulation (EU) 2017/746 (IVDR), FDA Code of Federal Regulations and Canadian Medical Device Regulations, Part 1 as well as regulations required for rest of world submissions.
Interpret complex legislation and provide expert advice to Alba Management and all staff on all aspects of US FDA, European and worldwide Regulatory Legislation relevant to Alba activities and collaborative undertakings with external organisations
Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standard, the 98/79/EC IVD Directive, Regulation (EU) 2017/746 (IVDR), FDA Regulations, Health Canada Medical Device Regulation, Part 1 (SOR/98-282)
Lead in the management, planning, coordination, preparation and interpretation of relevant information necessary for product license applications to ensure successful granting, maintenance and development of such licenses by the FDA including but not limited to BLA, 510(k) and PMA submissions for immunohaematology reagents.
Compile and submit initial registration/approval submissions in international markets post initial submission in EU, USA and other large territories
Compile product information for the preparation of technical files and regulatory dossiers to support product license applications and product license maintenance for worldwide Regulatory Authorities
Review analytical data from laboratory processes, clinical field trials and product evaluation data to support product registration and license applications
Advise Alba staff on data and information required for successful license applications and registrations and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

A relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
Extensive experience of filing US regulatory applications (BLA, 510(k), PMA submissions) and EU CE marking (IVDD/IVDR) applications.
Extensive post-market experience ensuring ongoing regulatory compliance Data analysis and interpretation skills.
Significant specialist knowledge of regulatory affairs as applied to in vitro diagnostic medical devices and an understanding of the operation of a medical device manufacturing establishment
Previous department management experience with strong leadership skills to manage a team. High sense of responsibility and accountability to ensure compliance and to inspire.

ADDITIONAL INFORMATION

Competitive salary on offer.
AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.

Apply Now

Refine Your Search

technical support specialist jobs in kirkliston, edh

Department Leader, Regulatory Affairs

Senior Application Support Consultant

Regional IT Support Specialist

Business Support Specialist

Transformation PMO Analyst

Project Manager/Business Admin Apprentice

Assistant Ecologist

Water Hygiene Risk Assessor - Scotland

Global Logistics Specialist

IT Support Specialist

JLR Diagnostics Technician

Support Administrator

Electrical Field Engineer

Senior Specialist, Regulatory & Technical Support, UK Trustee & Depositary

Biomedical Scientist - Annex21

Audit Assistant Manager - Scotland

Senior Information Security Specialist

Design Coordinator

Product Support Specialist - Institutions

SMCR Risk Consultant

I want to receive the latest job alerts for technical support specialist in kirkliston, edh

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected