Clinical Affairs Associate - Medical Device Manufacturer | Job in Wiltshire

We are seeking a dynamic and passionate Clinical Affairs Associate to join our team in the South West region. This role offers an exciting opportunity for a professional with a strong background in Medical Device Manufacturing and a keen interest in advancing patient care through innovative medical technology solutions. In this position, you will collaborate closely with various internal and external stakeholders, ensuring the successful integration of our products into clinical practice. Your responsibilities will encompass:

• Supporting the development and execution of clinical strategies to drive product adoption and optimize patient outcomes.
• Collaborating with healthcare professionals to gather valuable feedback on our products and provide education on their benefits and proper usage.
• Ensuring compliance with all relevant regulatory requirements and guidelines in the South West region.
• Working closely with cross-functional teams to address any clinical-related issues that may arise, contributing to continuous improvement initiatives.
• Staying abreast of industry trends and emerging technologies, leveraging this knowledge to proactively identify opportunities for product development and enhancement.
• Representing the organisation at relevant regional medical meetings and conferences, fostering strong relationships with key opinion leaders and industry peers. To succeed in this role, you should possess a degree in a relevant field (e.g., Medicine, Biomedical Sciences), coupled with several years of experience in Clinical Affairs or a related function within the Medical Device Manufacturing industry. Strong communication, organisational, and analytical skills are essential, as is the ability to work effectively both independently and as part of a team. If you're passionate about making a real difference in patients' lives through medical technology and thrive in a dynamic, fast-paced environment we would love to hear from you. Join our organisation and help shape the future of healthcare!

Role Description

We are a leading medical device manufacturer dedicated to advancing healthcare solutions and improving patient outcomes through innovation and technology. We are seeking an experienced and motivated Clinical Affairs Associate to join our dynamic team based in the South West region.

*Responsibilities: *

• Collaborate with internal teams, including R&D, Regulatory Affairs, Quality Assurance, and Marketing, to ensure a comprehensive understanding of our medical devices and their clinical applications.
• Develop, maintain, and update clinical evidence and data for our products, ensuring compliance with relevant regulatory requirements and industry standards.
• Contribute to the development of clinical trial protocols and related documents, working closely with investigators, ethics committees, and other stakeholders.
• Provide technical support and guidance to healthcare professionals on the appropriate use, safety, and efficacy of our medical devices.
• Participate in the preparation and submission of regulatory filings related to clinical evidence and data.
• Stay abreast of industry trends, emerging technologies, and regulatory changes to ensure our clinical strategies remain current and effective.

*Qualifications: *

• Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Nursing, or related Health Sciences) is required; advanced degree is preferred.
• Minimum of 3 years of experience in Clinical Affairs or Regulatory Affairs within the medical device industry.
• Strong understanding of clinical research, regulatory affairs, and quality management systems (e.g., ISO 13485, FDA QSR).
• Excellent written and verbal communication skills with the ability to present complex information clearly and concisely.
• Ability to work independently and as part of a team in a fast-paced environment.
• Strong organizational and project management skills with the ability to manage multiple projects simultaneously.
• Proficiency in relevant software applications (e.g., Microsoft Office Suite, electronic document management systems). Join our team and contribute to making a difference in healthcare through innovative medical devices! If you are passionate about Clinical Affairs and ready to take your career to the next level we encourage you to apply for this exciting opportunity today.

*Application Process: *

Please submit your resume, cover letter, and any relevant work samples or certifications via our online application system. Applications will be reviewed on a rolling basis until the position is filled. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We look forward to hearing from you!

Skill Set

In the role of Clinical Affairs Associate at a leading Medical Device Manufacturer in South West, you will be responsible for ensuring compliance with regulations and supporting the development of high-quality medical devices. The following skill set is essential to thrive in this dynamic and critical position.

• *Regulatory Knowledge

• : A comprehensive understanding of regulatory affairs specific to medical devices, including familiarity with MHRA (Medicines and Healthcare products Regulatory Agency), FDA (Food and Drug Administration), CE Marking, and other global regulations.

• *Clinical Research Experience

• : Proven experience in clinical research and trials, preferably within the medical device industry. Familiarity with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) is highly desirable.

• *Medical Device Expertise

• : A strong understanding of medical devices, their functionality, and application in healthcare settings. This includes knowledge of different types of medical devices (e.g., implantable, invasive, non-invasive), materials, and manufacturing processes.

• *Strong Communication Skills

• : Excellent written and verbal communication skills are crucial for liaising with various stakeholders, including regulatory bodies, healthcare professionals, and internal teams. The ability to articulate complex technical information in a clear and concise manner is essential.

• *Project Management Abilities

• : Experience in managing projects from conception through to completion, ensuring compliance with timelines, budgets, and quality standards. This includes the ability to prioritize tasks effectively and work collaboratively within cross-functional teams.

• *Quality Assurance & Risk Management

• : A strong understanding of quality management systems (e.g., ISO 13485) and experience in implementing risk management strategies to ensure product safety and efficacy.

• *Problem-Solving Skills

• : The ability to analyze complex problems, develop effective solutions, and implement these solutions efficiently. This requires a logical mindset, attention to detail, and the ability to think critically.

• *Continuous Learning Mindset

• : An eagerness to stay updated with the latest industry trends, regulations, and best practices. A commitment to lifelong learning is essential for success in this role. By possessing these skills and qualities, you will be well-equipped to make a significant contribution to our team's mission of improving healthcare outcomes through innovative medical devices. We look forward to your application!

Company Background

Welcome to a leading Medical Device Manufacturer based in the South West a dynamic and innovative organization at the forefront of advancing healthcare solutions. Established over two decades ago we have grown exponentially, becoming a trusted partner for hospitals, clinics, and medical professionals worldwide. Our commitment to quality, innovation, and patient safety drives us to constantly push the boundaries in the field of medical devices. Our team is composed of dedicated professionals who share a common goal: improving health outcomes through cutting-edge technology. We are proud of our collaborative work culture that encourages creativity, fosters learning, and values diversity. Our organisation believes in investing in its people offering opportunities for growth, development, and advancement within the company. As part of our team, you will contribute to our mission by supporting clinical affairs initiatives. This role is crucial in ensuring the successful integration of our medical devices into healthcare settings, enhancing patient care, and contributing to our long-term success. We look forward to your application and the unique skills and perspectives you will bring to our growing company.

Compensation and Benefits

At our organization we believe that our employees are our greatest asset and we strive to provide a comprehensive compensation and benefits package that reflects this value. As a Clinical Affairs Associate in the South West region, you will be eligible for the following: We offer competitive salaries commensurate with experience and qualifications. In addition, our performance-based bonus structure allows team members to share in the success of the organization. We provide comprehensive health, dental, and vision insurance plans for you and your family. Our goal is to ensure that all employees have access to quality healthcare services when they need them. To help you prepare for the future we offer a 401(k) retirement plan with company matching contributions. This is an excellent opportunity to save for your long-term financial goals while taking advantage of tax benefits. We understand the importance of work-life balance and provide generous paid time off (PTO) allowances so that you can recharge and spend quality time with loved ones or pursue personal interests. Recognizing that everyone has unique needs we offer a flexible work schedule to help our employees maintain a healthy lifestyle and manage their commitments outside of work. We are committed to the growth and development of our team members. We provide opportunities for continuous learning, training, and career advancement within the organization. Our Employee Assistance Program offers confidential support services to help you navigate personal or professional challenges that may impact your well-being. We hope this overview gives you a sense of what you can expect as part of our team. If you have any questions about our compensation and benefits package, please don't hesitate to ask during the interview process. We look forward to welcoming you to our organization!

Professional Development

In joining our team as a Clinical Affairs Associate at a leading Medical Device Manufacturer in the South West region, you will embark on an exciting journey of learning and growth within a dynamic and innovative industry. Our organization is committed to improving patient outcomes through cutting-edge technology, and we believe that investing in our people is essential to achieving this mission. Your role as a Clinical Affairs Associate will provide ample opportunities for professional development, both within your specific function and across the broader organization. Here are some key areas where you can expect to grow: Working closely with our Regulatory Affairs team, you will gain a deep understanding of global and regional regulatory requirements for medical devices. This includes familiarizing yourself with regulations from agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as other relevant national bodies. As part of this learning process, you will develop skills in creating and maintaining documentation, performing quality checks, and ensuring compliance with good manufacturing practices (GMP). As a Clinical Affairs Associate, you will have the opportunity to work on various clinical research projects. This will involve collaborating with our Research & Development team to design and execute studies that generate data supporting the safety and efficacy of our medical devices. You will learn about the entire clinical trial process, from study conception to final report writing, as well as developing an appreciation for statistical analysis and interpretation of clinical data. In this role, you will interact with a wide range of stakeholders, including healthcare professionals, regulators, and industry peers. These interactions will help you refine your communication and negotiation skills, as well as build a strong network within the medical device industry. You will learn how to navigate complex relationships while maintaining our organization's reputation for professionalism and integrity. Our organization values the importance of continuous learning and personal growth. To support this commitment we provide various resources and opportunities for professional development, including workshops, training programs, mentorship, and conferences. We encourage you to take advantage of these resources to expand your knowledge, skills, and network within the industry. By joining our team as a Clinical Affairs Associate, you will be part of an organization that is dedicated to supporting your professional growth while working towards a shared mission of improving patient outcomes through innovative medical devices. We look forward to welcoming you to our team!

Team Environment

Joining our Clinical Affairs Associate team in the South West region of a leading Medical Device Manufacturer represents an exceptional opportunity to contribute to the development and delivery of life-changing medical technologies. In this dynamic and collaborative environment, you will be part of a dedicated group of professionals who share a passion for improving patient outcomes through innovative product solutions.

• Collaboration: We recognize that our collective expertise drives better results. By working closely together we harness each other's unique skills and insights to tackle complex challenges and seize new opportunities.
• Integrity: Honesty, transparency, and accountability guide every decision we make. We are committed to upholding the highest ethical standards in all our actions.
• Innovation: Our team embraces change and encourages creativity, fostering an atmosphere where new ideas can flourish. By challenging conventional thinking we continually push the boundaries of what is possible.
• Patient Focus: Above all we prioritize the needs and wellbeing of patients. Our work is driven by the desire to provide effective solutions that make a meaningful difference in their lives. By joining our Clinical Affairs Associate team, you will have the opportunity to:
• Collaborate with cross-functional teams across multiple departments to develop and implement clinical strategies that align with our organization's objectives.
• Participate in the review of medical device studies, ensuring compliance with relevant regulations and best practices.
• Develop strong relationships with key opinion leaders, healthcare professionals, and other stakeholders to gather insights and feedback on our products.
• Contribute to the development of compelling and data-driven clinical evidence that supports our products' value proposition.
• Stay abreast of industry trends, regulatory changes, and emerging technologies to ensure our solutions remain at the forefront of medical innovation.
• Work in a supportive and inclusive environment where your ideas are valued, and your growth is encouraged through ongoing training and development opportunities.
• Contribute to improving patient outcomes by playing a crucial role in bringing life-changing medical devices to market. We invite you to join our team and become part of an organization that is committed to making a meaningful difference in the lives of patients worldwide. Together we can drive innovation, improve healthcare outcomes, and push the boundaries of what is possible in medical device manufacturing.