Sr. Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for blood products and biologics. Submissions will be at moderate to complex levels. 

Principal Responsibilities

•    Assume full responsibility for project submissions, including BLA, IND, 510(k) premarket notifications, and other documentation from guidance/strategies/authoring/obtaining approvals. 
•    Review and approve all labeling (product, advertising, instructions for use, and promotional) verbiage to ensure regulatory compliance and substantiated claims.
•    Interface with the FDA, applicable notified bodies, or other national health agencies regarding the development and review process to ensure submission approval and during audits to mitigate potential risks for new products and significant changes as needed.
•    Prepare regulatory strategies for intermediate to moderate-complexity projects for new products and product line modifications/extensions from development to launch.
•    Interpret existing regulations and guidance documents within the regulatory department, the business, and project teams. Understand and communicate regulatory requirements and what they mean to the organization and management.
•    Analyze changes for their impact on regulatory requirements and current filings, communicate the impact to the team, and complete the required documentation for decision.
•    Review and approve test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) to meet regulatory requirements.
•    Research, prepare, and present training to employees (peers and management) on market authorization trends, promotion and advertising, and other relevant regulatory topics with business impact.
•    Identify regulatory risk factors and contingency planning for assigned projects.
•    Prioritize projects independently based on department and corporate objectives.
•    Participate in product development through involvement in project team meetings, including risk assessment(s) as applicable.
•    Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and requests for information.
•    Apply understanding of the quality systems to ensure regulatory requirement compliance and to perform job activities and projects.
•    Bring Regulatory Affairs questions/issues to the attention of RA management. Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping. 

Education / Experience Requirements

•    A bachelor’s degree in a science or engineering field is preferred.
•    Five years of relevant regulatory experience required. Ideal candidates will have experience with commercialization efforts, creating/reviewing labeling and advertising/promotional materials for pharmaceuticals/biologics/medical devices, authoring, reviewing, and approving regulatory applications, analytical test methods, and justifications for specifications.
•    Experience with combination and biologic products is preferred 
•    Experience with design and manufacturing product transfers is preferred
•    Experience with facilitating both internal and external audits, i.e., FDA is required.
•    Proven history of successful domestic submissions. 
•    RAC certification preferred.
 

Specialized Skills / Other Requirements

•    Must be a well-organized self-starter who can work independently, pay attention to detail, and follow written and verbal instructions.
•    Manage assigned projects, suggest market authorization strategies, participate in cross-functional teams, and solve intermediate-level problems.
•    Working knowledge of US and international regulations applicable to market authorization for Interventional products, good verbal communication, technical writing, intra- and interdepartmental communication, and collaboration skills.
•    Comfortable operating in multiple Quality Systems.
•    Strong analytical and critical thinking skills, excellent verbal and technical writing communication skills, and strong organizational and time management skills with high personal and professional integrity and trustworthiness are all essential.
•    Strong work ethic and the ability to work independently, manage multiple projects with minimal direction, and meet deadlines. They should be customer-focused, committed to quality, and have problem-solving ability and orientation to teamwork.
•    Knowledge of electronic document management systems, basic understanding of and ability to comply with business and Regulatory Affairs ethical standards, and proficiency in MS Word, Excel, PowerPoint, and Outlook are required.

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