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- Tasks: Prepare documentation for international product registrations in the diagnostics industry.
- Company: Join a leading diagnostics provider focused on innovative testing solutions.
- Benefits: Enjoy remote work flexibility and a supportive team environment.
- Why this job: Make a real impact in healthcare while developing your regulatory expertise.
- Qualifications: Bachelor's degree in a relevant field and 4+ years in Regulatory Affairs required.
- Other info: Diversity is valued; all applications are welcomed.
The predicted salary is between 36000 - 60000 £ per year.
My client is a leading provider in the diagnostics industry, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. Their work provides critical information for the treatment and management of diseases and other health conditions.
We are currently seeking a Regulatory Affairs Specialist II within the Infectious Disease business unit. In this role, you will be responsible for preparing documentation for international product registrations.
This job description will be reviewed periodically and is subject to change by management.
Responsibilities:- Prepare technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation (IVDR).
- Provide regulatory support for diagnostic product development and commercial diagnostic products.
- Perform regulatory impact assessments to ensure compliance with international regulations and timelines.
- Coordinate with internal and external stakeholders to gather necessary information.
- Maintain up-to-date knowledge of regulatory changes and industry standards.
- Develop regulatory strategies for new and modified products to achieve international clearance/approval.
- Support regional regulatory teams with submissions, license renewals, and amendments.
- Research and communicate scientific and regulatory information to support submission documents.
- Compile and publish all material required for submissions, renewals, and annual registrations.
- Maintain approvals/licenses/authorisations for existing marketing authorisations.
- Assess product, manufacturing, and labelling changes for regulatory impact and compliance.
- Develop internal procedures and tools to enhance regulatory processes.
- Conduct informational or training sessions for stakeholders.
- Organise and maintain both hard copy and electronic department files.
- Demonstrate commitment to the development and effectiveness of the company's Quality Management System per ISO, FDA, and other regulatory agency requirements.
- Exhibit professionalism with internal and external business associates in alignment with company policies.
- Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or equivalent experience.
- 4+ years of experience in a Regulatory Affairs role.
- Strong knowledge of IVDR, EU, and international regulatory requirements.
- 1+ years of experience in an IVD or medical device manufacturing environment.
- Strong knowledge of EU and international regulations.
- Excellent written and verbal communication skills.
- Strong time management skills with the ability to manage multiple projects simultaneously.
- Ability to work both independently and within a team.
- Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Visio.
Candidates must be eligible to live and work in the UK.
Regulatory Affairs Specialist employer: Randstad Construction & Property
Contact Detail:
Randstad Construction & Property Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the In Vitro Diagnostic Medical Device Regulation (IVDR) and other relevant international regulations. This knowledge will not only help you understand the requirements of the role but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in diagnostics or medical devices. Engaging with industry experts can provide valuable insights and may even lead to referrals for job opportunities.
✨Tip Number 3
Consider joining relevant professional associations or groups focused on regulatory affairs. These platforms often offer resources, training sessions, and networking events that can enhance your knowledge and visibility in the field.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully navigated regulatory challenges or contributed to product approvals. Being able to articulate these experiences will set you apart during interviews.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Specialist II. Familiarise yourself with the In Vitro Diagnostic Medical Device Regulation (IVDR) and the specific requirements mentioned in the job description.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, especially any work related to IVDR or international regulations. Make sure to include specific examples of your past roles that align with the responsibilities listed in the job description.
Craft a Strong Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for the diagnostics industry. Mention how your skills can contribute to the company's goals and your understanding of their commitment to quality management systems.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Randstad Construction & Property
✨Know Your Regulations
Familiarise yourself with the In Vitro Diagnostic Medical Device Regulation (IVDR) and other relevant international regulations. Be prepared to discuss how your knowledge can contribute to compliance and regulatory strategies in the role.
✨Showcase Your Experience
Highlight your previous experience in Regulatory Affairs, especially any specific projects related to diagnostic products. Use examples to demonstrate your ability to manage multiple projects and meet deadlines.
✨Prepare for Technical Questions
Expect technical questions regarding regulatory documentation and submission processes. Brush up on your understanding of the requirements for international product registrations and be ready to explain how you would approach these tasks.
✨Communicate Effectively
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Be prepared to discuss how you would coordinate with internal and external stakeholders to gather necessary information.
