Regulatory Compliance Manager
1 week ago
Welland Medical Ltd is a leading company in the Healthcare and Medical Equipment industry, part of the Clinimed Holdings Limited group. We are committed to improving people's lives through innovative products and services.
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 regulatory strategies for new product development and registrations.
Key Responsibilities:
- Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
- Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
- Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
- Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
- Support all communications with regulatory authorities.
- Lead regulatory transition projects and other significant regulatory initiatives.
- Lead submission strategies for NPD projects and offer guidance on R&D product development.
- Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
- Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
- Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
- Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
- Monitor and review changes in regulations and standards, assessing their impact on the business.
- Create and maintain procedures to ensure ongoing regulatory compliance.
- Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
Requirements:
- Bachelor's degree (or equivalent) 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.
- Proven experience with medical device technical files and EU MDD/MDR requirements.
- In-depth understanding of the relationship between international standards and regulatory requirements, including the role of harmonized standards.
- Current specialist knowledge of medical device regulatory requirements in the EU and UK.
- Experience working within a Quality Management System certified to EN ISO.
- Additional qualifications in the field of medical device regulatory affairs.
- Demonstrable experience as part of a project team implementing significant regulatory transitions (e.g., experience working with non-EU medical device regulations).
- Project management experience.
-
Regulatory Compliance Manager
7 days ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading company in the healthcare industry, specializing in the development and distribution of medical devices. Our company is part of the Clinimed Holdings Limited group, a well-established organization with a rich history dating back to 1982.We are committed to delivering high-quality products that meet the needs of our...
-
Regulatory Compliance Manager
7 days ago
Crawley, West Sussex, United Kingdom Shaw Healthcare Full timeJob DescriptionCompany OverviewShaw Healthcare is a leading provider of healthcare services, dedicated to delivering high-quality care to individuals in need.Job SummaryWe are seeking a highly skilled Regulatory Compliance Manager to join our Clinical Governance Team. This role will involve planning, directing, and completing rigorous audits/inspections...
-
Regulatory Compliance Manager
1 week ago
Crawley, West Sussex, United Kingdom Lloyd Recruitment Services Ltd Full timeAbout the RoleLloyd Recruitment Services Ltd is seeking a skilled Compliance Specialist to join their team on a permanent basis.Key ResponsibilitiesMaintain and Enhance Quality Management System: Ensure alignment with relevant industry standards and best practices.Conduct Internal Audits and Quality Reviews: Identify areas for improvement and ensure...
-
Regulatory Compliance Lead
4 weeks ago
Crawley, West Sussex, United Kingdom Shaw Healthcare Full timeShaw Healthcare is seeking a Regulatory Compliance Lead to become a vital part of our Clinical Governance Team. This position offers a hybrid work model, requiring onsite presence for a portion of the week. Work Schedule: 37.5 hours per week Compensation: starting at £47,000, with potential increase to £49,000 upon successful completion of probation,...
-
Regulatory Compliance Coordinator
1 week ago
Crawley, West Sussex, United Kingdom Lloyd Recruitment Services Ltd Full timeAbout the RoleLloyd Recruitment Services Ltd is seeking a dedicated Compliance Administrator to join their team on a permanent basis. As a Compliance Administrator, you will play a crucial role in supporting the maintenance and improvement of the company's quality management system.Key ResponsibilitiesAssist in maintaining the quality management system,...
-
Crawley, West Sussex, United Kingdom Equiniti Full timeEquiniti: Regulatory Compliance and Risk Management PartnerEquiniti stands as a leading global provider of technological solutions in shareholder, pension, remediation, and credit services. Our dedicated team of over 6000 professionals serves 37 million individuals across 120 countries.In the role of Regulatory Compliance and Risk Management Partner, you...
-
Regulatory Compliance Coordinator
4 weeks ago
Crawley, West Sussex, United Kingdom The Best Connection Full time £24,250Join Our Team as a Regulatory Compliance Coordinator We are thrilled to present a fantastic opportunity to become a part of our dynamic and rapidly expanding organization as a Regulatory Compliance Coordinator. This pivotal position is essential for ensuring that all necessary regulations and standards for personnel in the aviation sector are adhered to. Key...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full timeAbout the RoleWe are seeking a highly skilled and experienced professional to join our team as the Head of Product Development and Regulatory Compliance at Rentokil Initial. This is an exciting opportunity to lead the development and launch of new and modified products that meet the requirements for cost, quality, service, and safety, while also ensuring...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full timeAbout the RoleWe are seeking a highly skilled and experienced professional to join our team as the Head of Product Development and Regulatory Compliance at Rentokil Initial. This is an exciting opportunity to lead the development and launch of new and modified products that meet the requirements for cost, quality, service, and safety, while also ensuring...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full time**About the Role**Rentokil Initial is seeking a highly skilled and experienced professional to lead our product development and regulatory compliance efforts. As the Head of Product Development and Regulatory Compliance, you will be responsible for developing and bringing to market new and modified products that meet the requirements for cost, quality,...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full time**About the Role**Rentokil Initial is seeking a highly skilled and experienced professional to lead our product development and regulatory compliance efforts. As the Head of Product Development and Regulatory Compliance, you will be responsible for developing and bringing to market new and modified products that meet the requirements for cost, quality,...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full timeAbout the RoleThis is a senior leadership position within the Product Development Consumable team at Rentokil Initial. The successful candidate will be responsible for developing and bringing to market new and modified products that deliver innovative solutions to meet the requirements for cost, quality, service, and safety, and environmental...
-
Crawley, West Sussex, United Kingdom Rentokil Initial Full timeAbout the RoleThis is a key leadership position within the Product Development Consumable team at Rentokil Initial, responsible for developing and bringing to market new and modified products that deliver innovative solutions to meet the requirements for cost, quality, service, and safety, and environmental considerations.The incumbent will work closely with...
-
Regulatory Affairs Lead
6 days ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading medical device manufacturer that has been a part of the Clinimed Holdings Limited group since 1982. Our company is built on a tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open...
-
Regulatory Affairs Lead
1 week ago
Crawley, West Sussex, United Kingdom Welland Medical Ltd Full timeAbout UsWelland Medical Ltd is a leading medical device manufacturer that has been a part of the Clinimed Holdings Limited group since 1982. Our company is built on a tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open...
-
Compliance Manager
1 week ago
Crawley, West Sussex, United Kingdom People's Partnership Full timeJob Title: Head of ComplianceJob Summary: We are seeking a highly skilled and experienced Compliance Officer to join our team at People's Partnership. As a key member of our organization, you will be responsible for developing and implementing effective compliance policies and procedures to ensure our business operations are in line with regulatory...
-
Compliance Manager
6 days ago
Crawley, West Sussex, United Kingdom People's Partnership Full timeJob Title: Head of ComplianceJob Summary: We are seeking a highly skilled and experienced Compliance Officer to join our team at People's Partnership. As a key member of our organization, you will be responsible for developing and implementing effective compliance policies and procedures to ensure our business operations are in line with regulatory...
-
Senior Regulatory Affairs Specialist
5 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 strong tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration,...
-
Senior Regulatory Affairs Specialist
1 week 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 strong tradition of improvement, ethical leadership, and total commitment to quality and safety.We're proud of our company culture, which is built on a foundation of collaboration,...
-
Compliance Manager
3 days ago
Crawley, West Sussex, United Kingdom Shaw Healthcare Full timeJob DescriptionJob Title: Compliance ManagerCompany: Shaw HealthcareLocation: UK basedJob Type: Full-timeContract: PermanentJob SummaryWe are seeking a highly skilled Compliance Manager to join our Clinical Governance Team. The successful candidate will be responsible for planning, directing, and completing rigorous audits/inspections across Shaw healthcare...
