Regulatory Affairs Manager
KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Chief Quality Officer
Type of employment: Permanent employment
Function: Quality / Audit / Corporate Governance
Location: Southend-on-Sea, England, United Kingdom
As Regulatory Affairs Manager, you will be responsible for managing and developing a team to support regulatory activities around the procurement and distribution of medical devices and products in the UK and Ireland region. Your key responsibilities will include managing registrations in the region, overseeing reviews of marketing materials, and providing regulatory support to the Commercial, Procurement, & Distribution functions, whilst ensuring regulatory compliance.
Please note: For the benefit of your team and stakeholders, a regular on-site presence is required; however, hybrid remote-working is in place and adopted by our team.
Your responsibilities
* Oversee regulatory authority registrations in the region.
* Work with Regulatory Intelligence counterparts to monitor the changing regulatory landscape in the UK and initiate required actions for regulatory compliance.
* Oversee change notifications for Olympus portfolio supplied in the region and assess regulatory impact.
* Provide regulatory support to Commercial, Procurement, & Distribution teams to ensure timely and effective market launch and supply.
* Review marketing materials.
* Develop and maintain associated processes and templates.
* Leadership and training of team.
* Audit subject matter expert.
Qualifications
* Degree-educated in a relevant subject, such as Biomedical, Pharmacy, Engineering, or similar.
* Demonstrated experience in Regulatory Affairs, Quality, or R&D in the Medical Device industry.
* In-depth knowledge of medical device regulations.
* Strong leadership skills, including the ability to confidently lead cross-functional discussions and drive projects to completion.
* Able to review and interpret regulations and standards.
* Ability to manage and prioritize multiple commitments.
* Effective communication skills; able to convey messages in a logical and concise manner.
* Exceptional attention to detail, with strong organizational skills.
* Able to build relationships with colleagues from different cultural and regulatory backgrounds worldwide, with diplomatic sensitivity.
Core Values
* 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 with a generous annual leave entitlement.
* Private medical cover.
* Comprehensive company pension scheme.
* Annual health check with BUPA, funded by us.
* Employee Assistance Program to support your health, mental and emotional well-being.
* Subsidized staff restaurant and free parking at HQ.
* Flexible working hours and hybrid remote working to support work-life balance.
* Discounted gym and wellness memberships, cashback, and discounts with major UK retailers.
Further information:
Valuing diverse perspectives and lifestyles is one of our core values. We encourage all people to apply - regardless of gender, nationality, ethnic and social origin, religion, age, disability, sexual orientation, marital status, identity, or conditions and restrictions which cannot be shown.
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