Department leader, regulatory affairs Work, Jobs in Kelty, Fif (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Team management
- Leadership
Team Leader
Eurofins UK BioPharma Services —Livingston
- Full-time
- Continuous improvement
- Quality control
- Mentoring
- Free parking
- Annual leave
Quick apply
Senior Regulatory Toxicologist
Ramboll —Edinburgh
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Business development
- Annual leave
Quick apply
Pupil Support Leader - Castlebrae Community Campus
City of Edinburgh Council —Edinburgh
- £64,659 a year
- Experience working with children
- Communication skills
- School
3h
Quality Analyst
Kerry —Clackmannanshire
- Weekend availability
- Microsoft Powerpoint
- Microsoft Word
- Quality control
Scientist-Analytical Research & Development
Veranova L P —Edinburgh
- Full-time
- Master's degree
- Bachelor's degree
- Annual leave
- Life insurance
Quick apply
ISO Lead Auditor / ISO Consultant - Perth
IMSM —Perth
- Hybrid work
- Organisational skills
- In-person
- Communication skills
Domestic Assistant
NHS Scotland —Cupar
- £26,696 - £28,988 a year
- Weekend availability
3d
255766 Advanced Nurse Practitioner
NHS Scotland —Livingston
- £52,845 - £61,466 a year
- Call to connect
- Nursing
5d
Team Manager Adult Services (Resources)
Fife Council —Fife
- £57,196.54 - £62,543.64 a year
- Full-time
- Hybrid work
- Supervising experience
- Team management
- Travel
- Employee discount
Team Leader
ASDA —Kirkcaldy
- £13.10 - £16.64 an hour
- Weekend availability
- Customer service
- Communication skills
- Annual leave
- Employee assistance programme
6d
Laboratory Assistant
E&O Laboratories Ltd —Bonnybridge
- From £12.71 an hour
- Full-time
- Computer literacy
- Laboratory experience
- Analysis skills
Quick apply
6d
Community Manager (Area)
Fife Council —Inverkeithing
- £70,430.40 - £84,227.40 a year
- Full-time
- No degree
- Leadership
- Communication skills
- Employee discount
R & D Scientist (Haematology)
AliveDx —Penicuik
- Full-time
- Data analysis skills
- Laboratory experience
- No degree
Depute Headteacher
Fife Council —Dunfermline
- £74,154 a year
- Part-time
- Continuous improvement
- Leadership
- School
- Employee discount
Laboratory Manager
Eurofins UK Environment Testing —Livingston
- Full-time
- Continuous improvement
- Computer skills
- Training & development
- Annual leave
- Employee assistance programme
Quick apply
Housemaster/mistress
Ministry of Defence —Dunblane
- £42,018 - £52,740 a year
- School
- Teaching
Proposals Coordinator
CYBERHAWK —Edinburgh
- £30,000 - £40,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- English
- Administrative experience
- Annual leave
- Employee assistance programme
4d
Constitutional Policy Higher Executive Officer - Scotland Office
Ministry of Justice —Edinburgh
- £30,001 - £50,000 a year
- Full-time
- Hybrid work
- Presentation skills
- Travel
- Organisational skills
- Annual leave
- Employee discount
2h
Shift Leader
Mowi ASA —Rosyth
- English
- Continuous improvement
- Team management

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Department Leader, Regulatory Affairs

AliveDx -
Penicuik

Apply Now

Job details

Permanent | Full-time

Benefits

Cycle to work scheme

Qualifications

Quality management
GMP
Compliance management
Team management
Data analytics
Leadership
ISO 13485
Corporate regulatory compliance oversight
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

department leader, regulatory affairs jobs in kelty, fif

Department Leader, Regulatory Affairs

Team Leader

Senior Regulatory Toxicologist

Pupil Support Leader - Castlebrae Community Campus

Quality Analyst

Scientist-Analytical Research & Development

ISO Lead Auditor / ISO Consultant - Perth

Domestic Assistant

255766 Advanced Nurse Practitioner

Team Manager Adult Services (Resources)

Team Leader

Laboratory Assistant

Community Manager (Area)

R & D Scientist (Haematology)

Depute Headteacher

Laboratory Manager

Housemaster/mistress

Proposals Coordinator

Constitutional Policy Higher Executive Officer - Scotland Office

Shift Leader

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