Regulatory Affairs Specialist

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Distribution Team, Quality, Labelling Team, Commercial, Clinical Team, R&D , Operations (Supply Chain)

Reports to: Manager RA

Function: Regulatory Affairs

Work Location/Site: Frankfurt, Germany

Role Overview

The Regulatory Affairs Specialist is responsible for the preparation and maintenance of registration files as well as for executing tasks related to the administrative processes of the product registrations in the EMEA region.

Duties and Responsibilities

• Provide an expertise regarding the applicable standards and regulations
• Preparation and submission of changes subject to approval by authorities.
• Establish, maintain and improve processes related to product registration and supporting activities.
• Support the business in obtaining on-time documents required to import/export products or to obtain reimbursement

Requirements

Experience

• Minimum 2 years’ experience in Regulatory Affairs in Medical Device/Pharmaceutical industry in EU, preferably in a multi-cultural environment.
• Experience with handling regulatory files and submission processes. 
• Preferably experience with medical devices (Class IIb and Class III)

Skills/Accreditations

• Experiences with documents for submission and the related preparation
• Experiences in evaluation of promotional and marketing material according to internal and external regulations
• Organized and structured way of working able to adhere to deadlines
• Excellent interpersonal and communication skills
• Able to work independently
• Meticulous and attention to details

Academic Qualifications

• Preferably a Bachelor (Hochschule) or University Degree in Science, Engineering, and/or Biotechnology or equivalent relevant experience

Travel requirements

• Up to 10%