- Understand and apply regulations, standards, and guidance documents from US, EU and Canadian geographies
- Prepare simple/intermediate/advanced regulatory strategies for new products and product line modifications/extensions
- Prepare regulatory submissions including: Pre-submission requests, post-approval submissions (e.g., Annual Reports, Changes Being Effect, Prior Approval Supplements, 180-day Supplements, 30-day Notices etc.), Regulatory File Memos, 510(k)s, technical files/design dossier to support self-authorizations and Notices of Changes, Canadian license amendments or applications, essential requirements checklists and work with regulatory agencies to obtain market authorizations
- Participate in product development through involvement in project team meetings, including risk assessment(s) as applicable
- Review and approve test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) to ensure they will meet regulatory requirements
- Assist in the development, review and approval of product labels, instructions for use, and promotional materials to ensure regulatory requirements are met.
- Analyze changes for regulatory impact. Communicate impact to team and complete required documentation for decision.
- Carry out assigned tasks, manage assignments, propose strategy.
- Prioritize and manage projects independently based upon department and corporate objectives.
- Research, prepare and present training to employees (peers and management) on Market Authorization trending, Promotion and Advertising, and other relevant regulatory topics with business impact.
- Identify regulatory compliance problems / recommend solutions
Note: 0% of this job involves direct R&D activities
EDUCATION / EXPERIENCE REQUIREMENTS:
- Bachelor's Degreerequired
- Five years of other relevant experiencerequired. Ideal candidates will have experience authoring / reviewing / or approving regulatory applications, analytical test methods, justifications for specifications.
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
- Must be a well-organized self-starter that takes the initiative for indpendent work with attention to detail and has an ability to follow written & verbal instructions.
- Manage assigned projects and related activities, propose market authorization strategies, effectively participate on cross-functional teams and identify and solve intermediate level problems.
- Must possess a basic understanding of product risk/benefit concepts, working knowledge of US & International regulations applicable to market authorization for Interventional products, good verbal communication, technical writing, intra- & interdepartmental communication and collaboration skills.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery.
We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.