Director of Regulatory Affairs

1 week ago

Fareham, United Kingdom DiverseJobsMatter Full time

JOB DESCRIPTION


Job title: Director, Regulatory Affairs (EMEA)

Department: EMEA Regulatory

Location: Delta Park, Segensworth

GLS: M5

Working hours: 37.5 Hours Weekly


A brighter future awaits you


We are one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of our company means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.


We’re big on belonging. Everyone’s contribution counts, and that’s why inclusion and diversity are so important. It isn’t just the right thing to do; it’s what makes our company the best it can be. We are committed to creating an inclusive and engaging workplace. Our Employee Resource Groups offer employees to grow within a safe and inclusive space. So be yourself, whoever you are, and let’s achieve amazing things together.


Job summary – What to expect:


As the Director of Regulatory Affairs EMEA, you will be responsible for leading, developing and implementing partnership strategies for regulatory approvals to support business plans.

As a subject matter expert, you will be expected to use your expertise to translate regulatory requirements into practical, innovative, workable, solutions-oriented plans via interacting directly with regulatory agencies and the implementation of the CVI Global QMS.


You will also ensure timely preparation of organized and scientifically valid submissions, providing expertise in translating regulatory requirements into practical, workable plans and interacts with regulatory agencies, R&D, Marketing, supply chain, and the regional RA staff within the business.

Within this position, you will have two direct reports (Senior Managers) and approximately 8 indirect reports. The teams are split between management of EU, UK and CH with the second team managing CIS, ACE and MENA regions.


This position leads against the RA Mission Statement: PROTECT the Business; GROW the Business. We will engage as trusted and strategic business partners, delivering pragmatic solutions and creative regulatory strategies to:


  • PROTECT the business and our freedom to operate.
  • GROW the business and create real advantages for customers and wearers.


About you:


We are looking for someone who has in-depth knowledge of EU MDR as well as strong working knowledge of EMEA Medical Device regulations.


Experience & Education:


Required


  • Bachelor’s Degree (B.A.) required. M.S. or higher degree preferred.
  • In-depth knowledge of the EU MDR.
  • Working knowledge of EMEA Medical Devices regulations.
  • Experience in Quality Management Systems, ISO13485 and MDSAP.
  • A proven track record in the management of regulatory compliance processes, recall, Adverse Event Reporting.
  • Ability to read and understand highly technical material and interpret regulations. Ability to work under pressure and adhere to deadlines.
  • Strong knowledge of international business, regulatory environments, regulations and legal product registration processes is required, as well as proficient product knowledge acquired through experience. Strong computer skills, problem solving ability, analytical and communication skills.
  • Significant experience in Medical Devices Regulatory Affairs
  • Required 8 years in a leadership role working across multiple countries, languages and cultures.


Preferred


  • Experience working in the Optical industry, specifically contact lenses is a plus.


Travel Requirements:


  • 30% within the EMEA region and globally to our offices.


Work Environment:


  • This is a hybrid office based role, based at our site near Southampton, Hampshire (PO15 5RL).
  • Relocation support will be considered within UK

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