Manager, Regulatory Affairs and Regulatory Compliance
We are seeking a talented Manager of Regulatory Affairs and Regulatory Compliance to lead one our Business Units and join our talented and growing team in the Dallas/Lewisville area.
This position is responsible for oversight of the development of regulatory submissions; departmental projects; provision of guidance and consultation for domestic and international regulations; interaction with governmental agencies and overseeing/managing a staff of regulatory professionals.
The Manager formulates strategic plans and develops departmental budgets. The Manager is also responsible for providing Regulatory guidance to the company, including DJO executive management and the Legal department, and must be aware of current developments and potential changes and opportunities in global regulatory jurisdictions.
Principal Duties and Responsibilities:
Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. Assists with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research.
Oversight of all regulatory functions, including regulatory submissions and development of dossiers for global registration. Develops and communicates regulatory strategy and manages staff to achieve key objectives; is alert to the potential to use new technology to achieve greater efficiencies. Assigns RA professionals to serve on development project teams as core team members. Manages and develops regulatory professionals to lead them to higher performance levels and maximize their career potential.
Provides training and guidance to all levels of professionals. Interprets and applies global regulations to business practices and provides regulatory input, advice and guidance to the organization. Manages and provides oversight for review of applicable marketing and published material to ensure they meet regulatory compliance. Assumes a leadership role among RA department, identifying best practices and provides regulatory input, advice and guidance to the organization. Responsibility for oversight and prioritization of departmental tasks and projects. Establishes and approves RA policy and procedures and ensures compliance with them. Develops the departmental budget and manages finances to achieve key objectives and optimize departmental function. Keeps all areas of DJO informed of regulatory requirements and emerging issues which may affect the registration approval of products. Communicates with regulatory and governmental agencies and supports audits by all regulatory agencies. Miscellaneous responsibilities as assigned.
Expected Areas of Competence (i.e., knowledge, skills and abilities):
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies, superiors, peers, and direct reports
Strong attention to details, and ability to multitask
Ability to manage projects of various sizes, constitutions, and management of personnel
Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs, combination products and IVDs as applicable
Mastery of product knowledge and industry history
Mastery of anatomic knowledge, especially orthopedic anatomy.
Able to identify and assess business risks and develop Regulatory strategy
Ability to negotiate with Regulatory agencies, management, and other groups as necessary
Ability to building relationships between RA and other parts of the organization
Ability to lead a team, influence others and, through strong organizational skills, handle increasing levels of responsibilities
Management and direct supervision of personnel. Ability to make independent decisions on resources and performance
Strong tactical and strategic thinking skills and administrative and leadership ability
Advanced knowledge of overall business environment, the orthopedic industry, and the marketplace
Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside the US/EU. This includes MDSAP, ISO 13485, MDR, and MDD requirements.
Bachelor's Degree (or non-US equivalent) required. Degree or background in life sciences, technical (engineering) or related field preferred
Advanced degree strongly preferred
Regulatory Affairs Certification (U.S. or EU) preferred
A minimum of 8 years prior RA experience
The incumbent's regulatory background should include the medical device area, and preferably should include orthopedic experience
Experience in the areas of drug, biologics, and combination products regulations is also desirable
A minimum of five years of experience managing direct reports
A combination of education and experience may be considered
Up to 20%
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.
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.