Senior Regulatory Affairs Associate - Medical Devices | Job in East Riding Of Yorkshire

In this exciting and challenging role as a Senior Regulatory Affairs Associate - Medical Devices within our dynamic organization, you will have the opportunity to shape the future of healthcare technology in Yorkshire and The Humber region. Our team is committed to delivering innovative medical devices that improve patient care and quality of life. As a key member of our Regulatory Affairs department, you will play a pivotal role in ensuring compliance with regulatory requirements throughout all stages of product lifecycle. The Senior Regulatory Affairs Associate - Medical Devices will work closely with cross-functional teams, including R&D, Quality Assurance, Legal, and Marketing, to ensure that our products are designed, manufactured, and marketed in accordance with applicable laws, regulations, and industry standards. Key Responsibilities:

• Develop and maintain regulatory strategies for new and existing medical device products.
• Ensure compliance with relevant regional and international regulations throughout the product lifecycle.
• Collaborate with cross-functional teams to prepare submissions for regulatory approvals and maintain registrations.
• Provide regulatory advice and guidance on current and emerging trends in medical devices.
• Participate in audits, inspections, and investigations as required by regulators.
• Keep abreast of changes in regulatory requirements and industry guidelines.
• Support the development and implementation of quality management systems to ensure compliance with regulatory requirements. To excel in this role, you should possess a strong understanding of medical devices regulation, preferably within the EU and UK markets. A degree in a relevant field such as Biomedical Engineering, Life Sciences, or Regulatory Affairs is essential. Proven experience in a similar role, ideally within a medical device manufacturing company, is highly desirable. This is an excellent opportunity for a proactive, detail-oriented professional to make a significant impact on the healthcare industry while working with a dedicated and forward-thinking team. If you are passionate about regulatory affairs in medical devices and ready to take your career to the next level we encourage you to apply. Join us today and contribute to our mission of improving patient care through innovative medical device solutions!

Job Role

In the dynamic and crucial field of medical devices we are seeking a highly skilled and experienced professional to join our team as a Senior Regulatory Affairs Associate. This role is based in Yorkshire and The Humber region.

*Responsibilities: *

• Develop and implement regulatory strategies for medical devices in accordance with national and international regulations.
• Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle.
• Prepare, review, and submit regulatory documentation to relevant authorities.
• Provide expert advice on regulatory requirements and implications to internal stakeholders.
• Stay abreast of changes in regulations and industry trends, and implement these updates within the organisation.
• Participate in audits, inspections, and other regulatory activities as required.
• Support the management of regulatory issues and respond to related correspondence in a timely and effective manner.
• Work closely with external regulatory affairs consultants, if necessary.
• Contribute to the continuous improvement of our regulatory affairs function.

*Qualifications: *

• Degree in a relevant field such as Life Sciences, Engineering, or a related discipline. A higher degree or relevant professional qualification is desirable.
• Proven experience in medical device Regulatory Affairs, ideally within a similar role.
• Extensive knowledge of medical device regulations in the UK and EU, as well as a strong understanding of global regulations.
• Excellent communication skills, both written and verbal with the ability to liaise effectively with internal teams and external regulatory authorities.
• Strong organisational skills and the ability to manage multiple tasks and projects concurrently.
• A results-driven mindset with a commitment to quality and compliance.
• The ability to work independently as well as part of a team.
• Flexibility and adaptability with the ability to respond effectively to changing regulatory requirements. By joining our organisation, you will become a key member of a dynamic team that values innovation, collaboration, and a commitment to excellence. We offer competitive salary and benefits packages, as well as opportunities for professional development and career advancement. If you are passionate about medical devices and Regulatory Affairs, and want to make a real impact in a growing organisation we would love to hear from you. Apply today!

Skill Set

As a Senior Regulatory Affairs Associate - Medical Devices in Yorkshire and The Humber, you will be expected to possess the following key skills:

*Regulatory Compliance Knowledge

• : A deep understanding of regulatory affairs for medical devices is essential. This includes knowledge of relevant global regulations such as EU MDR/IVDR, FDA QSR, and other local/regional requirements.

• *Strategic Thinking

• : The ability to develop and implement strategic plans to ensure regulatory compliance across product lifecycle is crucial. This involves understanding the impact of regulations on product design, development, and marketing.

• *Stakeholder Management

• : Excellent interpersonal skills are required for effective communication with internal teams, external partners, regulatory authorities, and customers.

• *Document Preparation and Submission

• : Experience in preparing and submitting technical documentation (e.g., IDEs, PMAs, MDD/MDR, CE marking applications) to relevant regulatory bodies is essential.

• *Quality Assurance

• : Familiarity with quality management systems (QMS) and experience in ensuring compliance with QMS requirements is highly desirable.

• *Problem-Solving

• : The ability to analyze complex problems, develop solutions, and implement them effectively is a key requirement for this role.

• *Continuous Learning

• : A commitment to staying updated with regulatory changes and trends within the medical device industry is essential to ensure ongoing compliance.

• *Project Management

• : Experience in managing multiple projects concurrently, meeting deadlines, and delivering high-quality results is a must.

• *Collaborative Approach

• : The ability to work collaboratively with cross-functional teams, including R&D, Quality Assurance, and Sales & Marketing, is crucial.

• *Adaptability

• : The willingness and ability to adapt to changing circumstances and priorities within the organization is essential. These skills will enable you to make significant contributions to our team's efforts in ensuring regulatory compliance for medical devices while driving innovation and growth in the industry.