Senior Regulatory Affairs Associate contract job

Related keywords: remote job internationalhybrid remote jobquality assurance remote job

Job Overview

The Senior Regulatory Affairs Associate position is a crucial opportunity at Walker Cole International, located in Scotland. This role offers a unique hybrid work model, allowing professionals to engage from home while collaborating on pioneering projects in the In Vitro Diagnostics (IVD) sector. It is an excellent fit for seasoned Regulatory Affairs specialists looking to elevate their careers in a collaborative and dynamic environment.

Responsibilities

The successful candidate will manage various tasks within the Regulatory Affairs domain, focusing primarily on IVD products throughout their lifecycle. Key responsibilities include:

• Leading and supporting all Regulatory Affairs initiatives related to IVD products.
• Preparing, reviewing, and maintaining comprehensive IVD regulatory submissions, including technical documentation for EU IVDR, UKCA files, and FDA submissions when relevant.
• Acting as the primary contact for Regulatory Affairs interactions with Notified Bodies, regulatory authorities, and internal stakeholders.
• Developing and supporting regulatory strategy for both new and existing IVD devices.
• Ensuring compliance with necessary regulations such as EU IVDR, IVDD, UKCA, and ISO 13485.
• Collaborating with cross-functional teams including Quality, R&D, Clinical, and Product Development departments to streamline processes.
• Continuously improving Regulatory Affairs documentation and processes.

Required Skills and Qualifications

To be considered for this role, candidates must possess the following qualifications and skills:

• Strong and proven experience in Regulatory Affairs within the IVD field, demonstrating an in-depth understanding of relevant processes and requirements.
• Extensive knowledge of EU IVDR, UKCA, and IVD regulatory frameworks is critical.
• Experience in compiling and managing IVD technical files and regulatory submissions is essential.
• Confident and effective communication skills when liaising with Notified Bodies and regulatory authorities.

Salary and Contract Type

While specific salary details are not disclosed in the job description, it is common for roles in this sector, particularly at a senior level, to offer competitive compensation. Typically, salaries for Senior Regulatory Affairs Specialists in IVD companies reflect industry standards and may include benefits associated with a full-time contract.

The job is classified as a Contract position, which may appeal to candidates looking for flexibility and the ability to manage their own working hours within a structured environment.

Work Environment

This hybrid role not only allows for professional and personal flexibility but also positions the candidate at the forefront of innovation in medical diagnostics. Working alongside a committed regulatory team, the incumbent will be part of impactful projects that aim to advance diagnostic technology.

Opportunities for Career Growth

Joining Walker Cole International offers a pathway to grow not only in professional expertise but also within the ranks of the organization. As a Senior Regulatory Affairs Specialist, you have the chance to deepen your experience working with cutting-edge medical devices and to contribute towards impactful changes in healthcare.

This position emphasizes a unique blend of hands-on work, strategic planning, and compliance assurance, making it an enriching experience for professionals eager to expand their careers in Regulatory Affairs.

In conclusion, the Senior Regulatory Affairs Associate role at Walker Cole International represents a prestigious opportunity to join a forward-thinking company engaged in pioneering IVD innovations. Candidates ready to accept the challenges and rewards inherent in this role will find themselves making a significant impact in healthcare and diagnostics.

This job offer was originally published on jooble.com