Job Description

Who We Are

ABOUT ENOVIS™

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. For more information about Enovis, please visit www.enovis.com

What You'll Do

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together.

As a key member, employees will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title

Regulatory Affairs Intelligence Project Manager

Reports To

VP RA, Recon and/or Dir/ Sr. Dir. RA

Business Unit(s) Description

Recon Corporate

Job Title/High Level Position Summary
This Regulatory Affairs (RA) Intelligence Project Manager is responsible for developing, facilitating and overseeing the process for managing standards and regulations impacting Recon business units (BUs). This role will establish and maintain a process by which the business remains compliant to external influences (medical device standards and regulations) through pro-active monitoring and critical assessments, orchestrate subject matter experts (SME) to determine, document and implement necessary changes to the QMS/processes/practices within impacted BUs. This role must communicate changes in regulatory/standards environments affecting the development, approval, and lifecycle management of Enovis Recon medical devices.

Essential Duties and Responsibilities:

• Primarily responsible for the establishment and maintenance of a process which will ensure Recon BUs remain in steady compliance to external influences. This process must comprehensively evaluate the impact of Regulations and Standards developments on Enovis’s current and future medical devices (pipeline and established marketed products).

• Monitor, react and interpret global regulatory developments, guidance documents, and policy changes from agencies such as FDA, EU MDR, TGA, Health Canada, ANVISA and other international regulators.

• Convene relevant SMEs to analyze the impact of regulation and standards & make interpretations of how best to comply to both statutory requirements as well as consensus Standards developments (such as ISO, EN or standards issued by ANSI, ASTM, ASME, etc.)

• Collaborate with SMEs to document gap analyses and implement required changes with the QMS to ensure Enovis current and future medical device products remain compliant to state-of-the-art requirements.

• Broaden awareness of external impacts to the global business.

• Analyze and synthesize the Regulatory Intelligence for reporting during periodic business reviews.

• Provide strategic regulatory guidance during all phases of product development, submission planning, and post-marketing phases.

Education & Experience

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s degree required (preferred: Master’s degree in relevant field: ie mechanical or biomedical engineering, engineering and/or natural sciences, health, law).

• Certifications such as Regulatory Affairs Certification (RAC) – Preferred not required.

• Minimum 6 years of relevant regulatory / medical device experience

• Solid understanding of regulated industries, preferably medical devices w/ experience in orthopedics, arthroplasty and SaMD / navigation design considerations

• Experience with maintaining Quality System compliance for medical solutions development and medical device / systems manufacturing

• Demonstrated ability to interpret changes, work collaboratively, assess impact, expertly guide the development of and maintain compliance to procedure / process for managing regulations and standards.

• Experience with global Health Authorities, including but not limited to: US FDA, EU MDR, Australia (TGA & PLAC mandatory)

• Self driven, player & coach, capable of managing without authority and organizing dynamic cross-functional teams

• Healthy communication and interpersonal skills

• Ability to manage complex initiatives and deliver to task

• Occasional yet routine work collaboration with US & EU time-zones required.

Working Conditions:

• Working conditions are an office setting; with occasional laboratory and manufacturing facility visits. Occasional travel may be required.

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.