Compliance Specialist
- Recruiter
- Confidential
- Location
- Limerick
- Salary
- 45000.00 - 50000.00 EUR Annual
- Posted
- 26 Jan 2022
- Closes
- 23 Feb 2022
- Sectors
- Manufacturing & Industrial
- Contract Type
- Permanent
- Hours
- Full Time
Compliance Specialist
Location: Limerick, Country Limerick
Salary: ???45K - ???50K - Depending on Experience + Excellent Benefits
Full time/Permeant
Remarkable Jobs are delighted to assist an established client of ours, with the recruitment of a 'Compliance Specialist'. This organisation has a strong presence within the Life Science / Biotechnology industries. Their mission is to improve patient healthcare by offering products and services that support accurate and reliable diagnostics results.
This 'Compliance Specialist' will provide support to this company's Manufacturing QA, R&D Quality, and Quality Systems areas from a regulatory perspective.
Key Responsibilities within this 'Compliance Specialist' role:
Providing updates and maintain status of product registration & notifications.
Compilation of global regulatory submissions, such as providing documentation requested from business partners.
Maintaining appropriate regulatory records to demonstrate compliance with the regulations.
Reviewing a list of all current and relevant standards, directives, CFR, and relevant Guidance Documents.
Observing all Health & Safety work requirements
Preparing Technical Files for product registration & submissions to EU and international competent authorities.
Organising appropriate regulatory records to ensure compliance with regulations.
Ensuring that labelling is meeting relevant standards and regulations.
Key Experience, Skills and Knowledge needed within this 'Compliance Specialist' role:
Degree/BSc in relevant Science, Engineering or Quality Assurance discipline.
3 years' experience within a similar role
Knowledge and experience working within regulated medical device/vitro environment.
Familiarity with ISO 14971
Knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC and IVDR 2017/746.
Excellent verbal and written skills
Strong initiative and troubleshooting skills required.
For immediate consideration, please apply today
Location: Limerick, Country Limerick
Salary: ???45K - ???50K - Depending on Experience + Excellent Benefits
Full time/Permeant
Remarkable Jobs are delighted to assist an established client of ours, with the recruitment of a 'Compliance Specialist'. This organisation has a strong presence within the Life Science / Biotechnology industries. Their mission is to improve patient healthcare by offering products and services that support accurate and reliable diagnostics results.
This 'Compliance Specialist' will provide support to this company's Manufacturing QA, R&D Quality, and Quality Systems areas from a regulatory perspective.
Key Responsibilities within this 'Compliance Specialist' role:
Providing updates and maintain status of product registration & notifications.
Compilation of global regulatory submissions, such as providing documentation requested from business partners.
Maintaining appropriate regulatory records to demonstrate compliance with the regulations.
Reviewing a list of all current and relevant standards, directives, CFR, and relevant Guidance Documents.
Observing all Health & Safety work requirements
Preparing Technical Files for product registration & submissions to EU and international competent authorities.
Organising appropriate regulatory records to ensure compliance with regulations.
Ensuring that labelling is meeting relevant standards and regulations.
Key Experience, Skills and Knowledge needed within this 'Compliance Specialist' role:
Degree/BSc in relevant Science, Engineering or Quality Assurance discipline.
3 years' experience within a similar role
Knowledge and experience working within regulated medical device/vitro environment.
Familiarity with ISO 14971
Knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC and IVDR 2017/746.
Excellent verbal and written skills
Strong initiative and troubleshooting skills required.
For immediate consideration, please apply today