Regulatory Intelligence Manager

OLYMPUS EUROPA SE & CO. KG; Southend-on-Sea; Hybrid; GBP 40,000 - 80,000; Full time

Job description

Regulatory Intelligence Manager

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Corporate

Type of employment: Permanent employment

Function: Quality / Audit / Corporate Governance

Location: Southend-on-Sea, England, United Kingdom

A global leader in the medical device and technology industry, for more than 100 years Olympus has focused on making people's lives healthier, safer, and more fulfilling. Our products and solutions help to diagnose, prevent, and treat illnesses, further scientific research and keep people safe.

As the Regulatory Intelligence Manager, your role will involve taking responsibility for monitoring the regulatory landscape and providing regulatory intelligence to various stakeholders on applicable regulations, standards and best practice guidelines.

Your Responsibilities

• Conduct regular monitoring of regulatory environment and identify regulatory intelligence which can affect portfolio and business operations.
• Develop expertise of local SMEs and provide support in keeping their knowledge up to date.
• Perform impact assessment of regulatory intelligence and disseminate to affected functions with action owners identified.
• Manage implementation of actions within reasonable deadlines.
• Participate in internal and external forums to obtain and share intelligence.
• Partner with Regional RA functions.
• Review procedures and templates and take ownership of certain procedures and templates.

Minimum Requirements

• University degree in a scientific subject such as Biomedical Science, Pharmacy, Engineering or a similar discipline is essential.
• Minimum of 3 years' experience in Medical Device regulatory affairs.
• Ability to review and interpret legislative text.
• Confidently lead cross-functional discussion and drive projects to completion.
• Ability to communicate and provide training on regulations and company policies and procedures.
• Effective communication skills and excellent attention to detail.

Please note - for the benefit of your team and stakeholders; you will be required to work from our UK Head Office in Essex, no less than twice per week.

Company 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.
• Eligibility for 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-wellbeing.
• Subsidised staff restaurant and free parking at HQ.
• Discounted gym and wellness memberships, cashback and discounts with major UK retailers.

Further Information

Valuing diverse perspectives and lifestyles is closely aligned with our core values. We encourage all candidates 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.