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For Companies At a Glance
- Tasks: Lead the development of diagnostic products from research to investigational use.
- Company: ARC Regulatory is a leader in innovative diagnostic solutions.
- Benefits: Enjoy flexible working options and a collaborative team environment.
- Why this job: Shape the future of healthcare while working with cutting-edge technology and diverse teams.
- Qualifications: PhD/MSc in Biological Sciences and 5+ years in IVD product development required.
- Other info: Ideal for those passionate about regulatory compliance and clinical innovation.
The predicted salary is between 54000 - 84000 £ per year.
ARC Regulatory is seeking a dynamic Head of Product Development – IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams.
Key Responsibilities
- Lead end-to-end IVD development from RUO to IUO.
- Define product roadmaps and oversee assay design, validation, and tech transfer.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971.
- Inspire cross-functional teams and collaborate with internal and external stakeholders.
- Oversee project timelines, budgets, and regulatory readiness for clinical trials.
Qualifications
- PhD/MSc in Biological Sciences or related field.
- 5+ years in IVD or life sciences product development.
- Proven experience in regulatory and clinical readiness for IVD products.
- Strong knowledge of design control, quality systems, and assay validation.
Preferred
- Experience with companion diagnostics or LDT strategies.
- Familiarity with digital health or SaMD.
Head of Product Development – IVD employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Product Development – IVD
✨Tip Number 1
Network with professionals in the IVD and life sciences sectors. Attend industry conferences, webinars, and workshops to connect with potential colleagues and mentors who can provide insights into the role and company culture.
✨Tip Number 2
Familiarise yourself with the latest trends and regulations in IVD product development. Understanding ISO standards and FDA regulations will not only boost your confidence but also demonstrate your commitment to compliance and quality.
✨Tip Number 3
Prepare to discuss your experience in leading cross-functional teams. Highlight specific projects where you successfully collaborated with regulatory, clinical, and QA teams to showcase your leadership skills and ability to drive results.
✨Tip Number 4
Research ARC Regulatory thoroughly. Understand their product portfolio and recent developments in their IVD offerings. Tailoring your conversation to reflect your knowledge of their work will show your genuine interest in the position.
We think you need these skills to ace Head of Product Development – IVD
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Head of Product Development – IVD position. Tailor your application to highlight your relevant experience in transitioning diagnostic products and managing cross-functional teams.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 5+ years of experience in IVD or life sciences product development. Provide specific examples of projects where you led product development from RUO to IUO, showcasing your knowledge of regulatory compliance and quality systems.
Showcase Leadership Skills: Since this is a senior role, it's crucial to demonstrate your leadership capabilities. Include instances where you inspired teams, managed budgets, and oversaw project timelines. Highlight any experience with cross-functional collaboration that aligns with the job description.
Tailor Your Application: Customise your application materials to reflect the specific requirements mentioned in the job description. Use keywords such as 'ISO 13485', 'FDA 21 CFR Part 820', and 'assay validation' to ensure your application resonates with the hiring team.
How to prepare for a job interview at HIRANI
✨Showcase Your Technical Expertise
Make sure to highlight your knowledge of IVD product development, especially your experience with transitioning products from RUO to IUO. Be prepared to discuss specific projects where you successfully navigated regulatory requirements and ensured compliance with standards like ISO 13485.
✨Demonstrate Leadership Skills
As a Head of Product Development, you'll need to inspire and lead cross-functional teams. Share examples of how you've effectively managed teams in the past, particularly in high-pressure situations, and how you foster collaboration among diverse stakeholders.
✨Prepare for Regulatory Questions
Expect questions about your familiarity with regulatory frameworks such as FDA 21 CFR Part 820 and IVDR. Brush up on these regulations and be ready to discuss how you've ensured regulatory readiness in previous roles, including any challenges you faced and how you overcame them.
✨Articulate Your Vision for Product Strategy
Be prepared to discuss your approach to defining product roadmaps and overseeing assay design and validation. Think about how you would align product strategy with market needs and technological advancements, and be ready to share your vision for the future of IVD products.
