Santa Clara, CA

Position Overview

The Sr. Director, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively manage assigned regulatory requirements. The Sr. Director, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures on both a strategic and tactical level that submission/registration/renewal deadlines are met, and supports new product development, when assigned. Effectively communicates and negotiates both internally and externally with various regulatory agencies. The Sr. Director, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, leading the coordination of activity across organizational units.
• Manage, mentor, and develop direct reports to meet individual and company goals and objectives, including accurate and on-time submissions/submission communication.
• Develop, follow, and train key personnel on regulatory policies, processes and SOPs.
• Develop and implement regulatory strategies and update strategy based upon regulatory changes.
• Determine submission and approval requirements in assigned geographies, collaborate with cross-functional teams for resourcing needs, and establish work plans/delegate assignments to Regulatory team in order to effectively meet the requirements.
• Provide strategic input and technical guidance on regulatory requirements to cross functional teams.
• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
• Effectively and accurately write and edit technical documents.
• Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
• Provide guidance to functional groups in the creation of relevant data to complete a regulatory submission.
• In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in countries where assigned.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
• Effectively communicate application progress to internal stakeholders.
• Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies.
• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
• Provide regulatory input for product recalls and recall communications.
• In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives.
• Review and approve advertising and promotional materials to ensure regulatory compliance.
• Evaluate, provide guidance and implement import/export requirements.
• Identify emerging issues and regularly communicate status.
• Exercise good and ethical judgment within policies and regulations.
• Perform multiple tasks concurrently with accuracy.

Requirements
• Bachelor’s degree in science, math, engineering, or medical fields is preferred. Post-graduate degree in a technical area, M.B.A. or law is preferred.
• 15+ years’ experience in a relevant/regulated healthcare industry.
• 12+ years of proven medical device regulatory experience. Class III medical device experience preferred.
• 5-7+ years’ prior management and positive mentorship experience.
• Medical device software engineering background or experience is preferred.
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
• Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions in various worldwide geographies.
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
• Ability to think analytically with excellent problem-solving skills.
• Effectively negotiate internally and externally with regulatory agencies.
• Clear and effective verbal and written communication skills with diverse audiences and personnel.
• Knowledge of business functions and cross group dependencies/ relationships.
• Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met.
• Leadership of functional groups in the development of relevant data to complete a regulatory submission.
• Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Effectively and positively lead direct reports while demonstrating flexibility to changing environments.
• Proficient in MS Word, Excel, Adobe and Power Point.