Senior Manager Global Regulatory Affairs

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

Job Description

Works closely with and have impact on: Global Team on New Product development

Reports to: RA Director Global

Function: Regulatory Affairs

Role Overview

The Sr. Manager Global Regulatory Affairs shall work with a high level of autonomy to bring medical devices to the global market. The incumbent participates on the product development team to provide regulatory guidance as assigned and manage Global regulatory strategy. This includes providing guidance on the regulatory requirements of new products or product modifications that may require IDE, PMA, PMA Supplements, 510(k)s for submission to FDA

Duties and Responsibilities

• Responsible for developing a global product regulatory strategy for surgical devices.
• Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
• Serve as Regulatory Affairs representative on project teams to develop and implement regulatory strategies for new product commercialization with key regulatory milestone, and activities for agency filing.
• Responsible for product registrations maintenance in in the US and LATAM regions.
• Track submissions and provide support for the US and OUS activities by coordinating with various functional team members such as Engineering, QA and Commercial to obtain necessary documents required for the timely submissions.
• Participate in change control process and determine whether and when product or process changes require regulatory action.
• Maintain up-to-date knowledge of regulatory requirements, particularly FDA, Canada and Latin America
• Participate in special projects and perform other duties as assigned by Director QA/RA Americas

Requirements

Experience

• Minimum 7 years working registration experience in Regulatory Affairs in Medical Device, Ophthalmic Surgical device experience highly preferred.
• Have experience in managing submissions in a multi-product, multi-country environment through third parties.
• Having experience with Global submissions including APAC and LATAM.
• Prior experience in NPD and Global Strategies.

Skills/Accreditations

• Excellent project management skills
• Excellent interpersonal and communication skills.
• Able to work independently with minimal supervision
• Strong technical writing skills.
• Good communication skills across different departments and organizations

Academic Qualifications

• Degree in Science or health relate field.
• Advanced Degree preferred

Travel requirements

• Occasional visits to Hoya sites <10%

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.