Current jobs related to Regulatory Expert - Longford - Life Science Recruitment
-
Medical Device Regulatory Expert
1 week ago
Longford, Ireland Vectura Group plc Full timeJob Description:Vectura Group plc is seeking a highly experienced Medical Device Regulatory Expert to join our team. This role plays a key part in ensuring compliance with European medical device regulations as our Authorized Representative.The successful candidate will contribute to global regulatory strategy and drive the approval process for all medical...
-
Regulatory Compliance Expert
2 days ago
Longford, Ireland beBee Careers Full timeJob Overview:">The Regulatory Affairs Specialist plays a vital role in supporting the regulatory activities for REACH projects across various sites.">Main Responsibilities:">Support the development and implementation of regulatory strategies for ongoing and planned REACH projectsCollaborate with cross-functional teams to achieve program goals and...
-
Regulatory Compliance Expert
6 days ago
Longford, Ireland beBee Careers Full timeOur ideal candidate will have a relevant third-level qualification to degree level, with 2-3 years' experience in regulatory, technical or quality areas within the devices or pharmaceutical industry.We are seeking an individual with advanced organizational skills and attention to detail, as well as the ability to work co-operatively and effectively with...
-
Longford, Ireland Vectura Group plc Full timeAbout Us:Vectura Group plc is an international company that develops innovative healthcare solutions for people around the world. Our team is made up of experts from various fields who work together to create groundbreaking products.Our Team:We're looking for a highly skilled Regulatory Affairs Manager for Medical Devices to join our team. As a member of our...
-
Regulatory Compliance Officer
2 days ago
Longford, Ireland beBee Careers Full timeAbout the RoleThis is an exciting opportunity for a Medical Device Quality Expert to join our team. As a key member of the quality department, you will be responsible for ensuring that our products meet the highest quality standards.Key Responsibilities:Drive improvements to the quality system to ensure its suitability, adequacy, and effectivenessUnderstand...
-
Medical Device Regulations Expert
2 weeks ago
Longford, Ireland Collins McNicholas Full time**About the Role**We are seeking a talented Medical Device Regulations Expert to join our team at Collins McNicholas. In this role, you will work on regulatory activities related to REACH projects, supporting the development of compliant documentation and submissions.Responsibilities:Analyze and interpret EU and international medical device regulations to...
-
Compliance Expert for Medical Devices
1 week ago
Longford, Ireland TN Ireland Full timeTN Ireland is a leading provider of innovative medical solutions, and we're looking for a dedicated Compliance Expert for Medical Devices to join our team. This is a fantastic opportunity to work in a collaborative environment, leveraging your expertise in Regulatory Affairs to drive compliance and quality excellence.Key Responsibilities:As a Compliance...
-
Environmental Assessment Expert
5 days ago
Longford, Ireland beBee Careers Full timeEnvironmental Assessment Expert:">We are seeking an experienced Environmental Assessment Expert to join our team and contribute to delivering high-profile projects throughout Ireland and nationally. As a key member of our multidisciplinary consultancy, you will play a vital role in assessing environmental impacts, mitigating risks, and ensuring regulatory...
-
Medical Device Compliance Expert
7 days ago
Longford, Ireland beBee Careers Full timeCompliance and Quality Assurance ManagerAbout the PositionWe are looking for a qualified Compliance and Quality Assurance Manager to lead our quality management systems and ensure compliance with relevant standards.This is an excellent opportunity for candidates with prior experience in medical device quality assurance and regulatory affairs.Primary...
-
Bioassay Expert for Pharmaceutical Projects
2 weeks ago
Longford, Ireland Quanta Consultancy Services Ltd Full timeWe are seeking a Bioassay Expert to join our team at Quanta Consultancy Services Ltd. As a QC Bioassay Analyst, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.About the ProjectOur client is currently working on exciting pharmaceutical projects, including the development and production of veterinary vaccines....
Regulatory Expert
2 weeks ago
Job Title: Senior Regulatory Affairs Specialist
Job Description: We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our client's team. The ideal candidate will have a strong background in regulatory affairs, with experience in managing technical documentation, global regulatory impact assessments, and regulatory procedures updates.
Key Responsibilities:
- Develop and implement strategies for regulatory compliance, ensuring our client's products meet strict industry standards.
- Manage technical documentation for regulatory submissions, including reports, policies, and procedures.
- Conduct global regulatory impact assessments to identify potential issues and opportunities for improvement.
- Update and maintain global regulatory procedures to ensure continued compliance with industry regulations.
- Provide regulatory support for R&D projects, including input and approval for new product introductions.
- Apply technical solutions to problem-solving and quality improvement projects, leveraging knowledge of regulatory requirements and industry best practices.
- Use technical writing skills to clearly describe technical information, preparing reports, policies, and procedures for regulatory submissions.
- Review and assess change control activities for potential impact on current regulatory filings, ensuring compliance with industry regulations.
- Maintain Regulatory procedures to ensure continued compliance with industry regulations.
- Ensure continual Quality System compliance by adherence to established and evolving internal requirements.
- Serve as RA team member for promotional materials review, experimental designs, data analysis, risk management, and product labeling as they relate to registration and commercialization of medical devices.
- Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues.
- Support Regulatory inspections at the site as directed.
- Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
- Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
- Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
Required Skills and Qualifications:
- Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
- Minimum of 3 years' experience in R&D, QA/RA, Validations.
- 3-4 years' experience in Risk, Clinical, and Biocompatibility – an advantage.
- Excellent technical writing experience within a medical device environment - essential.
- Attention to detail and accuracy – essential.
- Fluent in English, both written and oral - essential.
- Ability to work well under deadlines and pressure.
- Problem-solving skills for developing creative solutions and meeting objectives are required.
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook, and Excel).
- Excellent analytical ability.
- Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.
Benefits
This is an exceptional opportunity for a highly skilled Regulatory Affairs Specialist to join our client's team and contribute to the success of their medical device business.