Technical lead Work, Jobs in Lochgelly, Fif (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Management
- Data analysis skills
- Leadership
250268 Team Lead Breast Screening
NHS Scotland —Edinburgh
- £52,845 - £61,466 a year
- Call to connect
5d
Lead Consultant
Fife Council —Glenrothes
- £47,604.34 - £57,196.54 a year
- Full-time
- Hybrid work
- Maintenance
- Travel
- IT
- Employee discount
11d
Divisional Assessor
Fife Council —Glenrothes
- £57,196.54 - £62,583.94 a year
- Full-time
- Hybrid work
- Travel
- Employee discount
10d
Lead Consultant (Car Parking Strategy & Operations)
Fife Council —Glenrothes
- £47,604.34 - £57,196.54 a year
- Full-time
- Communication skills
- Employee discount
5d
Lead Cable Hand
Babcock International —Dunfermline
- £36,862 a year
- Full-time
- Supervising experience
- Leadership
- Annual leave
- Employee assistance programme
UK Technical Manager
Proclad —Glenrothes
- Full-time
- Engineering
- Master's degree
- Presentation skills
- Life insurance
Quality Lead
SSE —Perth
- £50,100 - £75,100 a year
- Engineering
- Continuous improvement
- No degree
- Employee discount
5d
Lead Technical Asset Manager
BayWa r.e. —Edinburgh
- Full-time
- Project management
- Driving
- Travel
- Employee assistance programme
- Employee discount
Technician Engineer
Fife Council —Glenrothes
- £34,914.86 - £43,437.09 a year
- Full-time
- AutoCAD
- Civil engineering
- Analysis skills
- Employee discount
12d
Front-End Technical Lead
Sky —Livingston
- Full-time
- Hybrid work
- Analysis skills
- JavaScript
- Mentoring
- Employee discount
Technical Services Manager - Electrical
Equans —Kirkcaldy
- Full-time
- Microsoft Word
- Microsoft Excel
- Administrative experience
- Annual leave
- Employee assistance programme
11d
Test Technician
Raytheon —Glenrothes
- Full-time
- Hybrid work
- School
- Relocation assistance
- Sick pay
Fleet Manager
EdinburghAirport —Edinburgh
- £54,813 a year
- Full-time
- Leadership
3d
OT Technical Support Manager
SSE —Perth
- £50,100 - £75,100 a year
- IT
- Employee discount
- Gym membership
5d
UK Technical Manager
Proclad Group —Glenrothes
- Full-time
- Engineering
- Master's degree
- Presentation skills
- Life insurance
Team Leader (Edinburgh Tram)
CAF Rail UK —Edinburgh
- £63,000 a year
- Communication skills
- Annual leave
10d
Squad Technical Lead
Aberdeen —Edinburgh
- Full-time
- Hybrid work
- Azure
- Continuous improvement
- Mentoring
- Annual leave
- Employee discount
Lead Consultant (Maintenance)
Fife Council —Fife
- £47,604.34 - £57,196.54 a year
- Full-time
- Maintenance
- Presentation skills
- IT
- Employee discount
Apprenticeships Audit - Apprenticeship Edinburgh Autumn 2026
KPMG —Edinburgh
- £25,500 - £28,000 a year
- Full-time
- Hybrid work
- Travel
- Leadership
- Accounting

I want to receive the latest job alerts for technical lead in lochgelly, fif

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 lead jobs in lochgelly, fif

Department Leader, Regulatory Affairs

250268 Team Lead Breast Screening

Lead Consultant

Divisional Assessor

Lead Consultant (Car Parking Strategy & Operations)

Lead Cable Hand

UK Technical Manager

Quality Lead

Lead Technical Asset Manager

Technician Engineer

Front-End Technical Lead

Technical Services Manager - Electrical

Test Technician

Fleet Manager

OT Technical Support Manager

UK Technical Manager

Team Leader (Edinburgh Tram)

Squad Technical Lead

Lead Consultant (Maintenance)

Apprenticeships Audit - Apprenticeship Edinburgh Autumn 2026

I want to receive the latest job alerts for technical lead in lochgelly, fif

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected