Regulatory Affairs Specialist

Enovis • Dallas, TX

1d

About The Position

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. The Regulatory Affairs Specialist is responsible for the development and implementation of the regulatory strategy (as applied to new product development projects, process, and/or product) and partners with internal stakeholders to align on an optimized regulatory strategy to achieve business objectives. This role is an active team member of the cross functional new product development team and provides hands-on regulatory affairs support, including development of regulatory requirements/strategies and preparation of submissions and EU MDR compliant technical documentation. The specialist will perform regulatory submission/approval activities, represent Regulatory with EU, US and international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards. The role requires creativity/innovation with expectations of use of accepted regulatory practices in the execution of tasks in collaboration with Senior Regulatory.

Requirements

• BS degree in Science or Engineering.
• 1 - 3 years’ experience in Global Regulatory Affairs, medical device or related industry experience, including EU CE Mark submissions, 510(k) submission experience, Health Canada submissions, and international market submissions.
• Basic understanding in software life cycle management, cybersecurity and data protection related to Medical Devices.
• Working knowledge and experience with quality systems regulations and guidelines, relevant ISO standards, GMP, Medical Device Regulations (MDR), FDA, TGA, and Canadian regulatory requirements.
• Demonstrates planning and organizational skills.
• Demonstrates ability to coordinate and work effectively with multiple stakeholders.
• Ensures timely, clear communications to internal stakeholders on project status and issues.
• Exhibits corporate Values and Behaviors.
• Demonstrates good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
• Meets individual goals as defined in the annual objectives.
• Ability to support the business by communicating effectively, including elevating concerns to management to address issues proactively, resolve conflicts, and mitigate risks.
• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
• Superior result oriented by taking initiative, executing per project plans, and holding self-accountable to meet commitments.
• Ability to operate effectively in a culturally diverse organizational structure, in addition to working independently with limited management oversight.
• Experience working globally and with global teams.
• Excellent proficiency in Business English and French.
• Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Nice To Haves

• EU submission, FDA, Health Canada and TGA experience.

Responsibilities

• Define regulatory requirements necessary for regulatory approval of products as part of the New Product Development Process and develop complete EU MDR Technical Documentation files.
• Complete regulatory assessments needed to support projects and provide direction to project teams on regulatory agency expectations and guidelines to support new product development and product modifications.
• Provide direction on application of external standards to project team.
• Develop and execute Global product submission strategies in collaboration with the Global Product Registration (GPR) team.
• Maintain regulatory documentation in accordance with departmental practices and quality system requirements.
• Support audits and participate in CAPAs, process improvements, and other special projects as needed.
• Maintain up-to-date training with SOPs, WIs, regulations, and applicable guidance documents.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees