Regulatory Affairs Manager – Medical Devices

G&L Healthcare Advisors is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.

We now have an exciting opportunity for a senior consultant in Medical Devices, to provide expert guidance and support across a variety of medical devices and combination products.

You’d be joining our international team of experienced Regulatory professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. A day in the life of one of our consultants may be varied and unpredictable – this opportunity is ideal for someone who thrives on challenges, enjoys client interaction, and guiding client programs through complex regulatory strategies. The successful candidate will be completely solutions-orientated with well-developed client management and customer service skillsets.

About Us:

We are a leading consultancy firm with offices on three continents, and we are building our specialist team of consultants with knowledge of medical devices, diagnostics, and combination products. Our team works closely with a wide range of clients from start-ups to established companies, helping them navigate the complex regulatory landscape and bring innovative products to market. Our projects cover everything from cutting-edge medical devices to companion diagnostics and combination products.

Key Responsibilities:

• Lead regulatory strategy and submission processes for a wide variety of medical devices and combination products, ensuring compliance with MDR, IVDR, and other relevant regulations.
• Support the development of companion diagnostic projects, providing regulatory expertise from the early stages through to product launch.
• Advise clients on the regulatory requirements for Laboratory Information Management Systems (LIMS), ensuring data integrity and system validation are in line with current regulations.
• Prepare and submit regulatory dossiers for combination products that incorporate both medical devices and pharmaceuticals.
• Ensure compliance with global regulatory frameworks, including FDA, EMA, and other international markets.
• Provide guidance on the post-market surveillance and risk management requirements for medical devices.
• Lead the regulatory efforts in product lifecycle management, from R&D through to commercialization, for a variety of device types.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to provide strategic regulatory input.
• Stay updated on the latest changes in global regulations, ensuring that all client projects meet evolving compliance standards.

What We're Looking For:

• Minimum 5 years of experience in Regulatory Affairs, specifically in the medical device industry.
• Strong knowledge of MDR, IVDR, and experience with FDA submissions.
• Experience with combination products and companion diagnostics.
• Understanding of LIMS regulatory requirements and validation processes.
• Familiarity with regulatory compliance for various medical device types (Class I, II, III).
• Excellent project management skills and ability to juggle multiple projects with competing priorities.
• Ability to provide clear and actionable regulatory advice across different stages of product development.
• Strong written and verbal communication skills, with a collaborative approach to working with diverse teams and clients.

Desirable skills:

• Experience with software as a medical device (SaMD).
• Knowledge of global market entry strategies for medical devices.
• Familiarity with regulatory processes in emerging markets.

Why Join Us?

• Opportunity to work on cutting-edge medical device projects across diverse fields.
• Collaborative and innovative environment with opportunities for professional growth.
• Competitive salary and benefits package.
• Flexible working arrangements (remote/hybrid).

If you are a highly skilled and versatile Regulatory Affairs professional looking for an exciting role with diverse challenges, we would love to hear from you!