Manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with International medical device regulations and overall regulatory departmental objectives, specializing in Asia Pacific markets. Develops, prepares, and maintains Asia Pacific regulatory filings and documentation as assigned to corporate objectives.
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks 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.
Experience in Regulatory Affairs with long-term implantable, cardiovascular devices strongly preferred.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
· Strong interpersonal skills including ability to interact with high degree of respect, professionalism and diplomacy.
· Success in obtaining timely market access.
· Good project management skills.
· Extensive knowledge of global medical device regulations and product development processes.
· Comprehensive knowledge of quality systems and application to function.
· Experience in developing and communicating global regulatory strategies
· Effectively interpret regulatory standards and guidance documents.
· Ability to work in a fast-paced, technically challenging environment where drive is critical to success
· Must be self-motivated, self-disciplined and able to effectively manage and communicate priorities.
· Expertise in Microsoft Office applications and charting programs.
· Effective problem solving techniques
· Excellent applied thinking and technical writing skills
· Strong communication and organization skills required.
· Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
· Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
· Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
· Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
· Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
· Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
· Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
· Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
· Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
· Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
· Computer Skills: Software proficiency in Microsoft Office Suite.
· Language Skills: Proficient in English. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
· Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
· Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form