The Director/ Vice President, Regulatory Affairs is primarily responsible for securing and maintaining regulatory clearance / licensure for company products in target markets, for providing strategic direction, oversight and alignment with company processes for all Regulatory Affairs functions and for ensuring company-wide compliance with all applicable U.S. and international regulatory requirements. The position will provide support for product development projects and commercialized product programs, and collaborate with key suppliers to ensure components and finished products manufactured for the company meet regulatory requirements. The position will deploy and support processes for effective Good Vigilance Practices, including adverse eventreporting and complaint handling as part of the Quality Management System. The successful incumbent will adapt creative problem solving skills to seamlessly meet business needs while maintaining regulatory compliance.
ESSENTIAL JOB RESPONSIBILITIES:
•Accountable for the overall management of the Regulatory Affairs function including organization design and performance management, budgeting and execution of strategic and operational objectives.
•Develop strategies and lead activities necessary for regulatory approvals in the US, EU, Canada, China, Japan, and other medical device markets worldwide.
•Assess and resolve regulatory issues associated with new product development and proposed device changes in close collaboration with other functions.
•Communicate domestic and international submission requirements to internal customers.
•Support preparation and submission of required information and monitor regulatory review progress through appropriate communication with the regulatory agency and/or registration agent.
•Maintain company-wide regulatory compliance, certify to new regulations/standards and maintain current licensure/certification.
•Lead company response to external regulatory agency inspections and third party audits of regulatory affairs.
•Lead the development of appropriate, timely responses to regulatory agency inquiries.
•Drive opportunities to streamline processes and successfully build organizational alignment. Lead RA department systems initiatives.
•Develop and reinforce corporate quality procedures including the maintenance of necessary regulatory and product documentation.
•Develop and lead employee training in regulatory requirements enabling compliance.
EDUCATION AND EXPERIENCE:
•Strongly prefer knowledge of Class I, II and III sterile/non-sterile medical device requirements.
•Strongly prefer extensive knowledge of ISO and FDA quality system requirements.
•Prefer experience handling FDA and Notified Body inspections.
•10 years experience in medical device / pharmaceutical Regulatory Affairs preferred.
•Prefer relevant professional certification(s) (e.g. RAPS, CQA, CQM and/or CQE).
•Bachelor’s Degree in a Science or Engineering field preferred.
SKILLS AND ABILITIES:
•Excellent communication skills and the ability to work with all levels of the Company. Superior verbal and written communication, teamwork and cross-functional interpersonal skills.
•Ability to interpret domestic and international regulations as they apply to company activities.
•Demonstrated ability to effectively lead amidst competing priorities to deliver on-time and within budget to support overall regulatory strategy and business objectives.
•Ownership and leadership of projects requiring multidisciplinary approaches and manage them to a successful conclusion.
•Ability to learn and understand the clinical procedural challenges within company markets.
•Effective problem solving to identify new and improved ways of doing business, analyze new opportunities efficiently and thoroughly and implement needed improvements.
•Strong commitment to excellence, “roll-up-your-sleeves” attitude and “hands-on” approach of an entrepreneurial environment.