Department leader, regulatory affairs Work, Jobs in Edinburgh, Sct (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Team management
- Leadership
Senior Regulatory Toxicologist
Ramboll —Edinburgh
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Business development
- Annual leave
Quick apply
Scientist-Analytical Research & Development
Veranova L P —Edinburgh
- Full-time
- Master's degree
- Bachelor's degree
- Annual leave
- Life insurance
Quick apply
GR - Clinical Support Worker, Clinical Research Facility
NHS Scotland —Edinburgh
- £29,103 - £31,409 a year
- Patient care
3h
Pupil Support Leader - Castlebrae Community Campus
City of Edinburgh Council —Edinburgh
- £64,659 a year
- Experience working with children
- Communication skills
- School
8h
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
7h
R & D Scientist (Haematology)
AliveDx —Penicuik
- Full-time
- Data analysis skills
- Laboratory experience
- No degree
Team Leader
Eurofins UK BioPharma Services —Livingston
- Full-time
- Continuous improvement
- Quality control
- Mentoring
- Free parking
- Annual leave
Quick apply
Proposals Coordinator
CYBERHAWK —Edinburgh
- £30,000 - £40,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- English
- Administrative experience
- Annual leave
- Employee assistance programme
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
Sustainability Advisor
Edinburgh Airport —Edinburgh
- Full-time
- Free parking
- Employee assistance programme
6d
Charge Nurse Team Leader (AA)
NHS Scotland —Dunfermline
- £43,231 - £52,679 a year
- Management
- Communication skills
- Nursing
3h
HR Employee Partner
Franklin Templeton Investments —Edinburgh
- Full-time
- Hybrid work
- Analysis skills
- Continuous improvement
- Communication skills
7d
Senior Legislation, Strategy and Coordination Adviser
The Electoral Commission —Edinburgh
- £40,031 - £42,033 a year
- Full-time
- Hybrid work
- Presentation skills
- Organisational skills
- Communication skills
- Annual leave
- Flexible schedule
7d
Careers, Skills & Academic Partnerships Manager
Edinburgh Napier University —Sighthill
- £46,049 - £58,225 a year
- Full-time
- Hybrid work
- Data analysis skills
- University
- Leadership
- Annual leave
- Employee discount
7d
Laboratory Manager
Eurofins UK Environment Testing —Livingston
- Full-time
- Continuous improvement
- Computer skills
- Training & development
- Annual leave
- Employee assistance programme
Quick apply
Replenishment Supervisor
Booker Group —Edinburgh
- Team management
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
6d
255766 Advanced Nurse Practitioner
NHS Scotland —Livingston
- £52,845 - £61,466 a year
- Call to connect
- Nursing
5d
Team Leader Search & Seal
gategroup —Edinburgh
- £14.31 - £15.74 an hour
- Full-time
- Supervising experience
- Quality control
- Training & development
Quick apply
Principal Scientist - Biophysics
Concept Life Sciences —Edinburgh
- Doctoral degree
- Business development
- Travel
- Free parking

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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 edinburgh, sct

Department Leader, Regulatory Affairs

Senior Regulatory Toxicologist

Scientist-Analytical Research & Development

GR - Clinical Support Worker, Clinical Research Facility

Pupil Support Leader - Castlebrae Community Campus

Constitutional Policy Higher Executive Officer - Scotland Office

R & D Scientist (Haematology)

Team Leader

Proposals Coordinator

Team Manager Adult Services (Resources)

Sustainability Advisor

Charge Nurse Team Leader (AA)

HR Employee Partner

Senior Legislation, Strategy and Coordination Adviser

Careers, Skills & Academic Partnerships Manager

Laboratory Manager

Replenishment Supervisor

255766 Advanced Nurse Practitioner

Team Leader Search & Seal

Principal Scientist - Biophysics

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