The Regulatory Affairs Specialist executes on global device and market registrations and compliance activities; provides product labeling details, technical and legalized documents as related to registration and commercialization of medical devices; collaborates with the regulatory staff from other business units and countries to understand global registration and market clearance requirements.
DUTIES AND RESPONSIBILITIES
This position supports the Company by performing the following duties:
· Interpret federal/state/international regulations as they apply to our products, processes, and procedures.
· Advise on impact of regulations, devises strategies for compliance, and acts as liaison with regulatory bodies.
· Investigate and resolve compliance problems, questions and complaints.
· Audit and evaluate current policies, procedures, and documentation for compliance with regulations and statues.
· Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates (e.g. CFGs, COO), and renewals (e.g. CE renewals) required to market company’s products in the geography.
· Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
· When needed train staff in regulatory policies or procedures.
· Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
· Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
· Coordinate internal discoveries and depositions with Legal Department.
· Excellent communication and interpersonal skills
· Excellent problem-solving abilities
· Ability to define problems, collect data, establish facts and draw valid conclusions
· ASQ certifications desirable (e.g. CQE, CQM, CQA)
· Strong project management skills preferred
· Strong Microsoft suite computer skills required
· Work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner
· Ability to lead, manage, and motivate a team through direct or indirect management
· Demonstrated technical analysis capabilities including analysis, process improvement methodologies, quality assurance concepts and systems, etc.
· Ability to work both independently and as part of a team and employ effective time management skills
EDUCATION AND QUALIFICATIONS
· Bachelor's degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 2 years of experience in the offered position or related.
· Experience preparing regulatory /market submissions including those for FDA 510(k) and establishment registrations, and Canadian site license renewals
· Experience applying international regulations including ISO 13485, IEC 60601-1 and 21 CFR 803, 806, and 820.
· Excellent communication skills when interacting with regulatory agencies including FDA, Heath Canada and other international agencies and responding to agency inquiries.
· Experience with MDSAP and other regulatory audits