Senior Regulatory Affairs Specialist

Job Description:
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 of the you 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:
Senior Regulatory Affairs Specialist
Reports To:
Director, Regulatory Affairs | Surgical
Location:
Austin, Texas (Hybrid 3 days onsite 2 day remote)
Business Unit Description:
Surgical | Reconstructive Medical Devices
Job Title/High Level Position Summary:
As a Sr Regulatory Affairs Specialist, you will work in the Global Regulatory Affairs department to establish and maintain appropriate systems to ensure Regulatory Compliance consistent with state, federal and international law. Assist customers by providing regulatory guidance and support as it applies to the use of Enovis Surgical devices.
Key Responsibilities:

• The incumbent is required to provide leadership and training to assure that all regulatory submissions and compliance matters are planned, communicated and executed per regulatory and business requirements.
• In addition, this position serves as a subject matter expert on various regulations as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources.
• Requires the ability to provide solutions based on their own knowledge and industry experience base.
• Prepare U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE products. Prepare regulatory submissions for health authorities in other countries. Prepare and maintain state and federal medical device licensing, establishment registration and listings. Obtain regulatory permits, including import / export clearance requirements.
• Regulatory assessment of new and changed products. Labeling / marketing material review. Participate in Project Teams and New Product Introduction Teams.
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate material to internal staff to aid in compliance.

Minimum Basic Qualifications:

• Must have a minimum of 5 years of Regulatory Affairs Medical Device technical work experience, or an equivalent combination of education and experience. Regulatory certification is a plus.
• Medical Device Regulatory Affairs: Regulations, Submissions (510(k), PMA, IDE), Technical Files, cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.
  Expertise in FDA regulations and guidelines
• Expertise in EU MDR requirements
• Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
• Familiar with using an eQMS system
• Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.

Education/Experience:

• Bachelor's degree in engineering, biology, chemistry, or related scientific discipline
• Advanced degree in engineering or scientific discipline preferred
• RAPS Regulatory Affairs Certification (RAC) preferred

Desired Characteristics:
• High energy level; positive attitude; works well under stress.
• Strong communicator.
• Hands-on, action-oriented, and able to implement effectively through his/her team.
• Continuous improvement minded; used to balancing the need for quality and the need for efficiency.
• Able to work autonomously in a matrix-managed organization.
• Willingness to travel (~5-10%).
• Comfortable with ambiguity and change.
• Track-record of working collaboratively with QA, R&D and Operations departments.
• Good business sense for what's practical, and what's not, what's needed for what parts of the business. Good sense for Operations in general. Able to effectively operate in a cost-conscious environment.
"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
Watch this short video and discover what creating better together means to us at Enovis:
Our Enovis Purpose, Values and Behaviors on Vimeo
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. Visit www.enovis.com to learn more.
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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.
ABOUT DJO GLOBAL
DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, Exos™, Dr. Comfort®, DonJoy Performance® and DJO® Surgical.
For additional information on the Company, please visit www.DJOglobal.com.
DJO is a growing subsidiary of diversified technology leader Colfax Corporation
EOE AA M/F/VET/Disability
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.