Regulatory Affairs Operations Specialist

Your role:

• Assisting, supporting, coordinating and preparing regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but typically not complex.
• The role works under general supervision, exercises independent judgment within established processes and fosters productive internal and external relationships to resolve mutual problems and contribute to streamlined operations.
• The role performs Change Management activities including hosting meetings to acquire change details for sustaining products, notifying geographical regulatory partners regarding changes for labeling, manufacturing, supplier, design, and software for regulatory compliance, reducing overall regulatory burden while ensuring full compliance.
• The role maintains comprehensive documentation and evidence to support audit defensibility, ensuring that processes and procedures can withstand regulatory scrutiny and audits.

You're the right fit if: (4 x bullets max)

1. Experience- 5+yrs of regulatory affairs experience in Medtech industry

2. Skills-

• Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
• Works under general supervision within established processes and operational policies, exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.
• Demonstrates basic understanding of regulator’s role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Applies analytical skills to resolve fewer complex requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
• Fosters productive internal and external working relationships to resolve mutual problems by conveying information, contributing to streamlined operations and improved outcomes, primarily communicating with internal contacts within the immediate group.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
• Works within standardized procedures and practices to achieve objectives and meet deadlines, making decisions that have limited impact on own work team and minimal impact on business.
• Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related control processes
• Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.

3. Education- Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent

4. Anything else- Good interpersonal skill, Quality mindset.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.