Regulatory Affairs Program Manager
Posted 5 hours 13 minutes ago by OLYMPUS EUROPA SE & CO. KG
KeyMed (Medical & Industrial Equipment) Ltd. (OKM) Chief Quality Officer
Type of employment: Permanent employment
Function: Regulatory
Location: Southend-on-Sea, England, United Kingdom
As a Regulatory Affairs Program Manager, you will coordinate regulatory activities across a diverse product portfolio, ensuring alignment and regulatory compliance across markets. You will serve as a strategic partner to internal teams, helping to define regulatory pathways and ensure consistent, compliant practices across the organisation. Combining strategic oversight with execution, this role offers significant visibility across regulatory, quality, manufacturing, and product development functions.
Your 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 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.
- Essential:
- 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.
- 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.
- Competitive salary.
- Generous annual leave entitlement.
- Private medical cover eligibility.
- Comprehensive company pension scheme.
- Annual health check with BUPA, funded by us.
- Employee Assistance Program to support health, mental and emotional well being.
- Subsidised staff restaurant and free parking at HQ.
- Discounted gym and wellness memberships, cashback and discounts with major UK retailers.
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. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to this role at Olympus, to apply.