Regulatory affair Work, Jobs in Scotland (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Management
- Data analysis skills
- Leadership
Clinical Site Manager (Continuous Glucose Monitoring)
Roche —Motherwell
- Bachelor's degree
- Mentoring
Product & Compliance Assistant
Novolex —Edinburgh
- £28,000 a year
- Full-time
- Hybrid work
- SharePoint
- Employee assistance programme
- Flexible schedule
Quick apply
7d
Senior Manager, Life Science and Healthcare Insights Lead, Clients & Markets
Deloitte —Aberdeen
- Hybrid work
- Project management
- Leadership
- Communication skills
Clinical Project Lead (Continuous Glucose Monitoring)
Roche —Motherwell
- Analysis skills
New Product Alliances & Innovation Lead
AliveDx —Penicuik
- Full-time
- Doctoral degree
- Leadership
- Communication skills
Senior Policy Officer - Scottish and Northern Irish Affairs
Information Commissioner's Office —Edinburgh
- £44,297 - £56,082 a year
- Full-time
- Hybrid work
- Presentation skills
- Travel
- Communication skills
- Annual leave
10d
Policy and Strategy Leads
Public Sector Resourcing —Edinburgh
- Full-time
- Analysis skills
- Communication skills
- Annual leave
13d
Regulation Manager
SSE —Perth
- £51,600 - £77,400 a year
- Full-time
- Computer networking
- Leadership
- Communication skills
- Employee discount
- Gym membership
9d
Policy Manager
Last Mile Group —Glasgow
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Employee assistance programme
Quality Systems Engineer
AliveDx —Penicuik
- Full-time
- Bachelor's degree
- Annual leave
Senior Trade Compliance Specialist - UK
Jabil Circuit —Coatbridge
- Full-time
- Bachelor's degree
- No degree
2d
Strategic Lead Finance (Corporate)
FWB —Inverness
- £84,102 - £91,946 a year
- Full-time
- Hybrid work
- Management
- Analysis skills
- Accounting
- Annual leave
Principal Licensing Consultant
SVT Licensing and Compliance Ltd —Edinburgh
- £62,000 - £85,000 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Mentoring
Quick apply
8d
Head of Corporate Communications & External Affairs
Highland Spring Group —Blackford
- Part-time
- Hybrid work
- Travel
- Leadership
- Sick pay
Quick apply
Legal Counsel, Technology, Commercial & Litigation
Aberdeen —Edinburgh
- Full-time
- Hybrid work
- Microsoft Outlook
- Financial services
- Annual leave
- Employee discount
Warehouse Operative / Relief Driver
Hilton Instruments Ltd —Aberdeen
- £25,528 a year
- Full-time
- Driving
- Warehouse experience
- Communication skills
Quick apply
Legal Counsel
Aberdeen —Edinburgh
- Full-time
- Hybrid work
- Continuous improvement
- Contracts
- Negotiation
- Annual leave
- Employee discount

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regulatory affair jobs near scotland

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

regulatory affair jobs in scotland

Department Leader, Regulatory Affairs

Clinical Site Manager (Continuous Glucose Monitoring)

Product & Compliance Assistant

Senior Manager, Life Science and Healthcare Insights Lead, Clients & Markets

Clinical Project Lead (Continuous Glucose Monitoring)

New Product Alliances & Innovation Lead

Senior Policy Officer - Scottish and Northern Irish Affairs

Policy and Strategy Leads

Regulation Manager

Policy Manager

Quality Systems Engineer

Senior Trade Compliance Specialist - UK

Strategic Lead Finance (Corporate)

Principal Licensing Consultant

Head of Corporate Communications & External Affairs

Legal Counsel, Technology, Commercial & Litigation

Warehouse Operative / Relief Driver

Legal Counsel

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