Responsibilities
* Lead coordination of regulatory activities across the product portfolio, to ensure alignment with global regulatory strategies
* Collaborate with regulatory counterparts to ensure consistency and standardisation across regions
* Facilitate the development of regulatory plans for new product development projects, novel technologies, and emerging market segments
* Support responses to regulatory authority requests and inquiries
* Contribute to both internal and external regulatory audits, ensuring preparedness and compliance
* Monitor and interpret evolving global regulatory requirements and assess business impact
* Support resolution of internal and external audit findings, including oversight of regulatory CAPAs
* Develop and maintain regulatory procedures to support consistent and compliant operations
* Provide regulatory support to cross‑functional initiatives, including manufacturing engineering, quality assurance, product development, and clinical affairs
Qualifications
* Experience in Regulatory Affairs within the medical device or healthcare industry
* Strong understanding of global regulatory frameworks
* Demonstrated experience supporting product development or regulatory strategy
* Experience supporting audits and regulatory authority interactions
* Ability to manage multiple programs and stakeholders simultaneously
* Strong communication and cross‑functional collaboration skills
Highly Desirable
* Experience within complex medical device portfolios
* Familiarity with global regulatory submissions and lifecycle management
* Experience managing CAPAs and regulatory compliance programs
Competencies
* Patient Focus – We put patients at the heart of everything
* Integrity – We do the right thing
* Innovation – We look for new ways to make things better
* Impact – We take accountability and get things done
* Empathy – We care for one another and work together
Benefits
* Competitive salary and generous annual leave entitlement
* Private medical cover
* Comprehensive company pension scheme
* Annual health check with BUPA, funded by the company
* Employee Assistance Program to support health, mental and emotional wellbeing
* Subsidised staff restaurant and free parking at HQ
* Discounts on gym and wellness memberships, cashback and discounts with major UK retailers
Additional Information
We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging. If you would like to bring your talents to this role at Olympus, please apply.
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