Regulatory Affairs Manager
Regulatory Affairs Manager | Medical Devices & Combination Products
An innovative healthcare start up is seeking a senior Regulatory Affairs professional to join the business during a critical growth phase. With multiple products progressing through development and commercialisation, this is an opportunity to build and lead the regulatory function while shaping the company's future regulatory strategy.
This role would suit someone who enjoys wearing multiple hats, thrives in a fast paced environment, and wants to play a key part in bringing novel healthcare products to market.
Responsibilities:
- Build and establish the Regulatory Affairs function from the ground up.
- Develop regulatory strategies across medical devices and combination products.
- Lead regulatory submissions and interactions with health authorities.
- Support product development, commercialisation, and future clinical activities.
- Partner closely with Quality, Manufacturing, and Senior Leadership teams.
- Provide regulatory guidance throughout the product lifecycle.
- Help drive business growth through effective regulatory planning and execution.
Experience Required:
- Strong Regulatory Affairs background within medical devices.
- Experience with Class IIb and/or Class III products.
- Proven experience developing regulatory strategy and submissions.
- Ability to work independently and influence senior stakeholders.
- Excellent communication and project leadership skills.
- Comfortable operating within a growing or entrepreneurial environment.
What's on Offer?
- Chance to build a regulatory department from the ground up.
- Work on innovative healthcare technologies and next generation products.
- Significant visibility and influence within the organisation.
- Flexible remote working.
- Opportunity to join a growing business at a genuinely exciting stage of its journey.
To learn more, apply directly or reach out.
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