Regulatory Program Specialist 4

Job Description:

Summary: With minimal direction from Director, Regulatory Affairs, this position is responsible for all activities related to achieving marketing authorizations in the US and in select International markets and in maintaining global regulatory compliance to national and international regulations and standards. This staff member will be responsible for managing all regulatory deliverables for select product lines throughout the product lifecycle from global regulatory strategy development through support of post market activities.

This role can sit in our Austin Texas location or Remote.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Develop global regulatory strategies for new product development initiatives, identifying streamlined and least burdensome pathways for marketing authorization of new or modified products
• Suggest and lead pre-submission meetings with FDA as determined to be necessary for select product development pathways
• Partner closely with clinical affairs in development and execution of clinical strategy and necessary clinical investigations and evaluations related to achieving marketing authorizations
• Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common specification conformance, current trends in thinking and decisions by regulatory authorities
• Execute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, Canada, Australia, Japan, Brazil and China, among others. This includes responding to requests from reviewers and resolving deficiencies in submissions.
• Partnering with Corporate Global Production Registration (GPR) team to coordinate and support select international registrations and maintain existing licenses and certifications through renewals
• Act as regulatory SME during technical documentation audits
• Perform regulatory assessment on product or process changes and execute necessary actions such as appropriate notifications, new 510ks, letters to file, technical file updates, license amendments, etc.
• Review and approve QMS change orders, design change orders, and NCMRs, ensuring changes don't impact safety and effectiveness of products without appropriate regulatory actions being taken
• Review labeling and marketing collateral to ensure compliance with regulations, approval conditions, and consistency of any claims with appropriate data
• Own and manage specific regulatory-related CAPAs, driving root cause investigation, implementation of actions, and confirming effectiveness
• Support completion of HHEs and work the Corporate Shared Services team to manage field actions and recalls
• Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance to new or modified requirements
• Maintain regulatory metrics for reporting to management, monitoring of effectiveness of regulatory processes and ensuring accountability to internal and external stakeholders
• Participates in the review of engineering specifications and quality programs in response to adverse quality levels or return trends.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

• Analytical - Synthesizes complex or diverse information.
• Design - Demonstrates attention to detail.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
• Project Management - Communicates changes and progress.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Strong ability to influence and persuade
• Written Communication - Writes clearly and informatively; Varies writing style to meet needs; Able to read and interpret written information.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Initiative - self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives
• Business Acumen - Understands business implications of decisions.
• Emotional Intelligence - Ability to navigate conflict and complex issues requiring interpersonal negotiation, self-regulate emotions and maintain perspective and professionalism during periods of stress
• Diversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
• Judgment - Exhibits sound and accurate judgment; Includes appropriate people in decision-making process.
• Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.

• Demonstrates commitment to the DJO Compliance & Ethics Program, the DJO Code of Conduct, the DJO Sales and Marketing Code of Conduct, the AdvaMed Code of Ethics, and all supporting and applicable regulations, policies and procedures.
• Demonstrates commitment to the DJO Values, Mission and Vision.

Skillsets & Qualifications

• Proven skills in preparing regulatory submissions in the US and Europe (510(k), De Novo and Technical Documentation). Experience with international regulatory submissions is a plus. Experience with IDE and PMA submissions a plus.
• Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
• 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.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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
• Minimum 8 years' experience in medical device regulatory affairs

Language Ability:

• Ability to read and comprehend simple instructions, short correspondence, and memos.
• Ability to write simple correspondence.
• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Math Ability:

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

• Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
• Ability to deal with problems involving a few concrete variables in standardized situations.

Computer Skills:

• To perform this job successfully, an individual should have solid skills in Excel, Word, Access, Microsoft Project and similar applications.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is regularly required to sit and use hands to finger, handle, or feel.
• The employee is frequently required to talk or hear.
• Employee must occasionally lift and/or move up to 25 lbs.

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.