Regulatory Affairs Specialist
7 days ago
Welland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and quality. Our mission is to bring the best products to market, enhancing the lives of people living with a stoma worldwide.
Job OverviewWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a pivotal role in supporting the business by developing regulatory strategies for new product development and registrations. Your expertise will ensure compliance with all relevant regulations and standards across the business.
Main Responsibilities- Lead a regulatory team, ensuring compliance with EU MDD/MDR Class I and/or Class II devices.
- Collaborate with regulatory authorities to achieve successful product registrations.
- Develop and implement regulatory strategies for New Product Development (NPD) projects.
- Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, and dossiers.
- Provide regulatory support for sales and commercial activities.
- Lead interactions with Notified Bodies on regulatory affairs matters.
- Support all communications with regulatory authorities.
- Lead regulatory transition projects and other significant regulatory initiatives.
We are looking for a candidate with a Bachelor's degree in a scientific, engineering, legal, or regulatory discipline. Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency is essential. You should have demonstrable experience working with EU MDD/MDR Class I and/or Class II devices and a comprehensive knowledge of EN ISO 13485.
Strong leadership skills, attention to detail, and excellent written and verbal communication skills are required. Ability to manage competing priorities and workloads to meet deadlines is essential. Additional qualifications in medical device regulatory affairs and project management experience are desirable.
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeJoin Our Team as a Senior Regulatory Affairs SpecialistWelland Medical Ltd is a leading company in the healthcare industry, and we're seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.About the Role:Develop and implement regulatory strategies for new product development and registrations.Manage the upkeep of all regulatory...
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Regulatory Affairs Specialist
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeJoin Our Team as a Senior Regulatory Affairs SpecialistWelland Medical Ltd is a leading name in the Healthcare and Medical Equipment industry, and we're looking for a highly skilled Senior Regulatory Affairs Specialist to join our team.About the Role:Develop and implement regulatory strategies for new product development and registrations.Manage the upkeep...
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Regulatory Affairs Specialist
7 days ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeJoin Our Team as a Senior Regulatory Affairs SpecialistWelland Medical Ltd is a leading name in the Healthcare and Medical Equipment industry, and we're looking for a highly skilled Senior Regulatory Affairs Specialist to join our team.About the Role:Develop and implement regulatory strategies for new product development and registrations.Manage the upkeep...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeJob DescriptionWelland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group.Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Senior Regulatory Affairs Specialist, you will play a pivotal role in supporting the business by developing...
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Regulatory Affairs Specialist
7 days ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our team is dedicated to...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our team is dedicated to...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a strong reputation for improvement, ethical leadership, and commitment to quality and safety.We're passionate about making a difference in the world and investing in talented people to...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the healthcare and medical equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a strong reputation for innovation and quality.We are passionate about making a difference in the world through our products and services. Our company culture is built on collaboration,...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a strong tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, built on collaboration, teamwork, and open...
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Regulatory Affairs Specialist
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a strong tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, built on collaboration, teamwork, and open...
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Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. Founded in 1982, the group has a rich history of innovation and excellence.We are passionate about creating world-class products that enhance the lives of people living with a stoma. Our commitment to quality,...
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