Regulatory Specialist

4 weeks ago

Abingdon, United Kingdom Revvity Full time

Job Overview: Regulatory Specialist

Company: Oxford Immunotec
Location: Abingdon, UK
Position Type: Fixed-Term, 9 months
Work Arrangement: On-site OR REMOTE

Company Overview: Oxford Immunotec, a Revvity company is a leading global diagnostics company dedicated to bringing energy and innovation to the field of diagnostic testing. We offer regulated ELISPOT assays for T cell measurement, providing diagnostic solutions approved around the world.

Role Summary: Oxford Immunotec is seeking a Regulatory Specialist to join our team for a fixed term of 9 months . The Regulatory Specialist will support the Global Regulatory activities within Oxford Immunotec (Revvity). The Regulatory Specialist will work with the company's regulatory process leading to timely product approval for both new and existing products in line with company goals. The regions covered compose of Africa, LATAM, Middle East, and India. The candidate must have IVD/Medical Device industry experience.

Role Description:

Overall responsibilities:

To assist the Regulatory team with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.

To provide Global regulatory support to Sales and Commercial teams for ongoing requests for documents and information

Specific deliverables for the role are:

To work with the Quality team to ensure that verification and validation activities as well as risk management are carried out to support Global regulatory requirements

To provide support to OI’s facilities to ensure that any regulatory needs are covered.

To take a supporting role in the preparation for and implementation of the requirements of global IVD Regulations.

To take a central role with documentation and to support regular communication with regulatory authorities to ensure that we are in compliance with their requirements

To take a supporting role with the provision of regulatory affairs input to research and development programs in order to ensure that these programs deliver products that are capable of early product approval by regulators

Communication with distributors to ensure good relationship management from a regulatory perspective when required

To assist with the maintenance of OI certification to international quality standards to ensure regulatory compliance (ISO 13485, ISO 17025 and GMP)

To provide review of sales and marketing documents from the regulatory perspective

To work with and support the Regulatory Officer to ensure that any annual administrative regulatory tasks are carried out in a timely manner.

Operate effectively across departmental boundaries to resolve regulatory related issues in collaboration with peer group and other stakeholders

Working to Company Values at all times.

Role Requirements

Technical skills and abilities

Educated to degree level or higher or with a minimum of 5 years relevant experience within IVD/MD Quality Assurance, Regulatory Affairs, or similar environment

Good working knowledge of MS programs, the Internet and databases

Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP

Good understanding of the submissions process, ideally in a medical device/diagnostics field.

Strong written and oral communication skills

Understanding of the scientific, biological and technical issues involved in developing diagnostic assays

Experience of the conduct of Internal and External Quality audits

Emotional skills and abilities

Ability to think analytically, to solve problems and identify solutions

Ability to work with minimal supervision•Attention to detail

Ability to continue to learn new skills and adapt to new ideas

Excellent interpersonal skills employed to communicate with individuals on all levels and from different areas of the business

Ability to manage people effectively

Team working profile with a co-operative and proactive attitude to other staff, collaborators and senior managers

Bright, energetic and enthusiastic

What we Offer:

Purposeful & inclusive work environment

Dynamic culture in which customers are at the forefront

Being part of a highly qualified team that is committed to excellence

Access to cutting-edge expertise through which you can make positive impact in the world around us

#LI-EMEA

  • Senior Regulatory Specialist

    2 months ago

    Abingdon, United Kingdom Coburg Banks Full time

    A high-growth global healthcare company is currently looking for a Senior Regulatory Specialist to join their UK headquarters in Abingdon, Oxfordshire. You would assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the company’s regulatory process, leading to timely product approval for both new and existing products. The role...

  • Senior Regulatory Specialist

    1 month ago

    Abingdon, United Kingdom Coburg Banks Limited Full time

    A high-growth global healthcare company is currently looking for a Senior Regulatory Specialist to join their UK headquarters in Abingdon, Oxfordshire. You would assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the company'sregulatory process, leading to timely product approval for both new and existing products. The role...

  • Regulatory Specialist

    2 months ago

    Abingdon, United Kingdom Revvity Full time

    This position is offered as a fixed term contract (FTC) of circa 9 months and is responsible for Global Regulatory activities within Oxford Immunotec (Revvity) Role Description: Overall responsibilities: To assist the Regulatory team with the Company’s regulatory process leading to timely product approval for both new and existing products in line...

  • Senior Regulatory Specialist Ftc

    2 days ago

    Abingdon, United Kingdom Revvity Full time

    We are currently seeking a Senior Regulatory Affairs Specialist to join us on a Maternity cover (fixed term contract) of circa 12 months. This position is responsible for Global Regulatory activities within Oxford Immunotec Ltd. **Role description** **Overall responsibilities**: - To assist the Director of Regulatory Affairs and the Head of Regulatory...

  • Senior Regulatory Specialist FTC

    4 days ago

    Abingdon, United Kingdom Revvity Full time

    We are currently seeking a Senior Regulatory Affairs Specialist to join us on a Maternity cover (fixed term contract) of circa 12 months. This position is responsible for Global Regulatory activities within Oxford Immunotec Ltd. Role description Overall responsibilities: To assist the Director of Regulatory Affairs and the Head of Regulatory Affairs...

  • Senior Regulatory Specialist

    2 months ago

    Abingdon, United Kingdom Oxford Immunotec Full time

    Overview: - To assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals. - To provide Global regulatory support to Sales and Commercial teams for ongoing requests for documents and...

  • QA Specialist

    3 days ago

    Abingdon, United Kingdom Evotec Full time

    We are currently recruiting an experienced QA Specialist to join the team at Milton Park, Abingdon, Oxfordshire. This is a permanent position to start ASAP. Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics,...

  • Hsse Specialist

    2 months ago

    Abingdon, United Kingdom Infineum Full time

    **Date**:7 Jun 2023 **Location**: Abingdon, GB, OX13 6BB **Company**:Infineum **About Us** **We create a sustainable future through innovative chemistry.** Infineum is a world leading formulator, manufacturer and marketer of petroleum additives for fuels and lubricants. Infineum additives are in 1 in 3 vehicles worldwide, and are designed to improve...

  • Pharmaceutical Operator Specialist I

    1 day ago

    Abingdon, United Kingdom Evotec Full time

    We currently have a number of openings within our Pilot Plant for shift working Pharmaceutical Operator Specialists. This is a permanent position starting ASAP, working 12-hour shifts (days and nights). Role & responsibilities - Operate the pilot plant reactors and ancillary equipment following all current procedures (IOPs, BPGs, etc.) to maintain high...

  • Pharmaceutical Operator Specialist I

    5 days ago

    Abingdon, United Kingdom Evotec Full time

    We currently have a number of openings within our Pilot Plant for shift working Pharmaceutical Operator Specialists. If you have just graduated in either Chemistry or other related discipline, this could be the opportunity that you are looking for, alternatively you may already have some experience in this area and be looking for your next career...

  • Quality Specialist Iii

    3 days ago

    Abingdon, United Kingdom Evotec Full time

    Our Company Evotec, Aptuit’ s parent company, is a leader in the discovery and development of novel therapeutics of all modalities with operational sites in the UK, Europe (Germany, Italy and France) as well as the US. Aptuit Oxford provides integrated Chemistry, Manufacturing and Control capabilities to fully support drug substance development and GMP...

  • Senior Commercial Procurement Specialist

    1 week ago

    Abingdon, United Kingdom Adecco Full time

    We have an exciting new role become available for an experienced Senior Commercial Procurement Specialist to work for the Civil Nuclear Constabulary at their headquarters in Culham Oxfordshire. This is a 6 month contract from the start date, start date will be confirmed following successful vetting being carried out. You will be working Monday to Friday...

  • Specialist Operator

    3 weeks ago

    Abingdon, Oxfordshire, United Kingdom Evote Full time €22,000

    PHARMACEUTICAL OPERATOR SPECIALIST l Role: Pharmaceutical Operator Specialist I Starting from £22,000 with shift allowance of £8,196. Plus annual bonus and annual merit review Hours: 12-hour shifts (days and nights) including paid breaks (90 minutes). Shift Pattern: 28-day shift pattern cycle: week 1: 2 dayshifts, 2 nightshifts, 3 days off ...

  • Research and Development Specialist

    3 weeks ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Specialist, Travel and Expense Services Vacancy Name Specialist, Travel and Expense Services Employment Type Permanent IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases...

  • Quality and Compliance Manager

    2 weeks ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title: Quality and Compliance Manager Location: Didcot Quarter (near Milton Park), Abingdon Salary: £45,000 FTE per annum, plus bonus Job Type: Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), Permanent Start Date: ASAP We are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas...

  • Quality and Compliance Manager

    1 week ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title:Quality and Compliance ManagerLocation:Didcot Quarter (near Milton Park), AbingdonSalary:£45,000 FTE per annum, plus bonusJob Type:Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), PermanentStart Date:ASAPWe are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas within the...

  • Quality and Compliance Manager

    2 weeks ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title: Quality and Compliance Manager Location: Didcot Quarter (near Milton Park), Abingdon Salary: £45,000 FTE per annum, plus bonus Job Type: Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), Permanent Start Date: ASAP We are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas...

  • Quality and Compliance Manager

    7 days ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title:Quality and Compliance Manager Location:Didcot Quarter (near Milton Park), Abingdon Salary:£45,000 FTE per annum, plus bonus Job Type:Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), Permanent Start Date:ASAP We are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas within the...

  • Quality and Compliance Manager

    2 weeks ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title: Quality and Compliance ManagerLocation: Didcot Quarter (near Milton Park), AbingdonSalary: £45,000 FTE per annum, plus bonusJob Type: Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), PermanentStart Date: ASAPWe are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas within the...

  • Quality and Compliance Manager

    2 weeks ago

    Abingdon, United Kingdom Simon Hegele Full time

    Job Title: Quality and Compliance ManagerLocation: Didcot Quarter (near Milton Park), AbingdonSalary: £45,000 FTE per annum, plus bonusJob Type: Full Time (40 hours per week) or Part Time (minimum 25hrs per week +), PermanentStart Date: ASAPWe are seeking a career minded Quality and Compliance Manager to assist our Head of Compliance in key areas within the...