Regulatory Affairs Senior Associate Contract Job

Related keywords: entry level remote jobremote job entry levelremote job international

Job Overview

The position available is for a Senior Regulatory Affairs Specialist with a focus on In Vitro Diagnostics (IVD) at Walker Cole International, located in Scotland. This is a contract role that offers a hybrid working environment, allowing for both remote work and in-person collaboration. The hiring company is a recognized leader in the field of IVD, and this role presents an opportunity to be an integral part of a growing regulatory team, particularly in relation to innovative diagnostic products.

Key Responsibilities

As a Senior Regulatory Affairs Specialist, the selected candidate will have a diverse range of responsibilities that include:

• Leading and supporting Regulatory Affairs activities throughout the product lifecycle specifically for IVD products.
• Preparing, reviewing, and maintaining regulatory submissions related to IVD, including technical documentation necessary for compliance with EU IVDR, UKCA, and FDA standards.
• Acting as the main point of contact for Notified Bodies, regulatory authorities, and internal stakeholders, which is critical for ensuring smooth regulatory interactions.
• Playing a key role in the development of regulatory strategies for both new and existing IVD devices, thereby influencing their market entry and compliance trajectory.
• Ensuring continuous compliance with various regulatory frameworks, including EU IVDR, IVDD, ISO 13485, and other relevant guidance documents.
• Collaborating across teams, including Quality Assurance, R&D, Clinical, and Product Development, highlighting the importance of cross-functional teamwork in regulatory activities.
• Contributing to the processes of continuous improvement within Regulatory Affairs, enhancing efficiency and effectiveness in documentation and compliance practices.

Required Skills

To qualify for this role, applicants should exhibit the following skills and qualifications:

• Demonstrated experience working within Regulatory Affairs, specifically in the In Vitro Diagnostics sector.
• A strong understanding of both EU IVDR and UKCA requirements, as well as the broader IVD regulatory frameworks.
• Proven capability in compiling and maintaining IVD technical files and completing necessary regulatory submissions accurately and in a timely manner.
• Confidence and experience in navigating relationships with Notified Bodies and various regulatory authority representatives, as this is a vital part of the role.

Salary Information

While the job description does not specify a salary range, it is not uncommon for roles of this seniority in the regulatory affairs field to be compensated competitively, reflective of the candidate's expertise and experience level in IVD regulatory practices. Interested candidates are encouraged to inquire further about remuneration during the interview process.

Opportunities for Career Development

This role is particularly suited for experienced Regulatory Affairs professionals who are eager to advance their careers in a dynamic and evolving industry. The hybrid nature of the position not only facilitates an optimal work-life balance but also enhances collaboration among teams, providing a supportive environment for professional growth. The company's commitment to innovation within the diagnostics sector presents an exciting backdrop for individuals aiming to elevate their careers in Regulatory Affairs.

Conclusion

In summary, this opportunity with Walker Cole International represents a significant step for professionals motivated to work in Regulatory Affairs within the In Vitro Diagnostics space. The chance to contribute to pivotal regulatory processes while working within a hybrid environment positions this role as a prime selection for job seekers looking to make an impact in a reputable and expanding IVD organization.

This job offer was originally published on jooble.com