Regulatory affairs lead Work, Jobs in Clifton Hampden, Oxf (with Salaries)

Senior Specialist Regulatory Affairs
Abbott Laboratories —Witney
- Full-time
- Maintenance
- Bachelor's degree
- Communication skills
SVP Regulatory Affairs & Quality Assurance
PrecisionLife Ltd —Oxford
- £85,000 - £105,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Computer Science
- Engineering
- Free parking
- Annual leave
Quick apply
4d
Northern Europe Regulatory Affairs Director
Kenvue —Reading
- Hybrid work
- English
- Analysis skills
- Bachelor's degree
Head of Spectrum & Regulatory Affairs
Open Cosmos —Didcot
- Hybrid work
- English
Senior Communications and Corporate Affairs Lead
LEO Pharma A/S —Maidenhead
- Marketing
- AI
13d
Principal Scientist, Bioanalytical & Molecular Assays
Moderna, Inc. —Oxford
- Full-time
- Doctoral degree
- Master's degree
- Annual leave
Director, Medical Affairs (Europe & International)
Immunocore —Oxford
- Doctoral degree
- Travel
- Patient care
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Leadership
- Communication skills
- Annual leave
- Employee discount
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Associate Director, Regulatory Project Manager
CSL Behring —Maidenhead
- £170,000 - £210,000 a year
- Full-time
- Doctoral degree
- PMP
- Master's degree
PV Systems and Processes Lead x2
CSL Seqirus —Maidenhead
- Full-time
- No degree
- Leadership
- Communication skills
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Director, Medical Affairs EMEA
Kenvue —Reading
- Hybrid work
- Management
- Continuous improvement
- Travel
- Annual leave
6d
Head, PV and Regulatory QA
CSL Seqirus —Maidenhead
- Full-time
- Customer service
- Bachelor's degree
- Organisational skills
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Senior Scientist I – Biocompatibility
Abbott Laboratories —Witney
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
BUH UKI Nordics Advanced Surgery
Baxter —Newbury
- £120,000 - £165,000 a year
- Management
- Master's degree
- Bachelor's degree
12d
Senior Medical Advisor
LEO Pharma A/S —Maidenhead
12d
Director - Regulatory Platforms
CSL Behring —Maidenhead
- Full-time
- Computer Science
- Bachelor's degree
- Travel
12d
Associate Director, Clinical Trial Disclosure & Transparency
CSL Behring —Maidenhead
- Full-time
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Communication skills
2d

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regulatory affairs lead jobs near clifton hampden, oxf

Senior Specialist Regulatory Affairs

Abbott Laboratories -
Witney

Apply Now

Job details

Full-time

Benefits

Company pension
Private medical insurance

Qualifications

Maintenance
Bachelor's degree
Communication skills

Full job description

Senior Specialist Regulatory Affairs

Location: Witney

Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.

Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

World Leader in Glucose Monitoring, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes.

The site has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System as well as exciting developments in the Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and the Libre Sense system. We are passionate about doing work that improves the quality of people’s lives.

We’re hiring a Senior Specialist Regulatory Affairs to join the EMEAP regulatory affairs team, which is growing to meet the demands of the business and to support a strong product pipeline.

Primary Job Function

You will be responsible for a portfolio of cutting-edge medical devices & IVDs, leading regulatory activities for new product introductions and significant on-market changes for the Europe, Middle East, Africa and Pakistan (EMEAP) region. You will work as part of a global team, to develop, lead and implement strategies that will ensure the timely introduction of new products onto the international market in a fast-paced environment.

You will coordinate and oversee preparation of complete and scientifically sound regulatory submissions and lead interactions with the Notified Body and country regulatory contacts to facilitate the regulatory submission review process to ensure a timely approval process.

Core Job Responsibilities

Formulate, develop and lead business critical regulatory strategies for the EMEAP region.
Act as the regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches.
Become a technical expert in ADC devices and support interactions with EU Notified Body/UK Approved Body, as well as competent authorities, as required
Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and other application regulations.
Provide coaching and mentoring to more junior team members
Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.

Education

Bachelor’s degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.

Minimum Experience Required

Knowledge of MDR 2017/745 Regulations and ISO13485 is essential, additionally, knowledge of IVDR 2017/746 is preferred
Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
Experience of Technical File creation and maintenance, as well as post market changes
Experience of working with Notified Bodies and/ or other regulatory bodies
You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.

In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements.

Apply Now

Refine Your Search

regulatory affairs lead jobs in clifton hampden, oxf

Senior Specialist Regulatory Affairs

SVP Regulatory Affairs & Quality Assurance

Northern Europe Regulatory Affairs Director

Head of Spectrum & Regulatory Affairs

Senior Communications and Corporate Affairs Lead

Principal Scientist, Bioanalytical & Molecular Assays

Director, Medical Affairs (Europe & International)

Senior Benefits Risk Management Lead

Local Study Associate Director

Associate Director, Regulatory Project Manager

PV Systems and Processes Lead x2

Associate Director Global CMC QU – Clinical GMP/GDP

Director, Medical Affairs EMEA

Head, PV and Regulatory QA

Associate Director Global CMC QU – Clinical GMP/GDP

Senior Scientist I – Biocompatibility

BUH UKI Nordics Advanced Surgery

Senior Medical Advisor

Director - Regulatory Platforms

Associate Director, Clinical Trial Disclosure & Transparency

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