Regulatory affairs Work, Jobs in Kirkcaldy Central, Fif (with Salaries)

Department Leader, Regulatory Affairs
AliveDx —Penicuik
- Full-time
- Management
- Data analysis skills
- Leadership
Regulation Manager
SSE —Perth
- £51,600 - £77,400 a year
- Full-time
- Computer networking
- Leadership
- Communication skills
- Employee discount
- Gym membership
11d
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
10d

Discover related jobs

Based on your search for regulatory affairs jobs.

Medical Writer - Publications
Real Chemistry —Edinburgh
Use a range of resources to understand the underlying science and product strategy related to assigned projects. Adhere to quality control processes, including:
Principal Medical Writer
Real Chemistry —Edinburgh
Identify key actionable insights, recommendations, opportunities, threats, and critical success factors to inform product strategies.

I want to receive the latest job alerts for regulatory affairs in kirkcaldy central, fif

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

Explore jobs in more locations

regulatory affairs jobs near kirkcaldy central, fif

Principal jobs in Edinburgh

Principal Data Scientist jobs in London

Principal Support jobs in Rotherham

Principal Social Worker jobs in Cardiff

Principal Software Engineer jobs in Manchester

Head Of Pe Department jobs in London

Worship Leader jobs in London

Department Leader jobs in Southampton

Manager jobs in Leeds

Health Safety Manager jobs in London

Regulation Manager jobs in Leeds

Regulation Manager jobs in Lancaster

Catering Manager jobs in London

Warehouse Manager jobs in Leicester

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 affairs jobs in kirkcaldy central, fif

Department Leader, Regulatory Affairs

Regulation Manager

Principal Licensing Consultant

Discover related jobs

I want to receive the latest job alerts for regulatory affairs in kirkcaldy central, fif

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected