Director of Regulatory Affairs

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Full-time Regular Senior Management Whitestown, IN, US

30+ days ago Requisition

SCOPE OF WORK SUMMARY

• Be responsible for all matters related to regulatory affairs.
• Coordinate and facilitate US regulatory submissions and international (Outside US or OUS) regulatory registrations.
• File for and maintain CLIA waivers when needed.
• Approve product labeling, ensuring compliance with requirements.
• Participate in review, approval, and implementation of product changes.
• Provide guidance on regulatory requirements for business partners and internal customers.
• Provides advice and strategy planning with regards to compliance issues related to the FDA and OUS regulatory requirements, particularly in the USA, UK, EU, Canada, Mexico, Brazil, Australia, and Japan.
• Be responsible for US Medical Device Reporting and global vigilance reporting.
• Serve as European Person Responsible for Regulatory Compliance.
• Collaborate with Sinocare and sister company to support inter‑company projects
• Provide guidance on regulatory requirements for business partners and internal customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• This is an on‑site position. Remote work is not suitable for this position.
• Write, update, and file US regulatory submissions including 510(k)’s, CLIA submissions and FDA correspondence relating to issues as required.
• File and update international regulatory submissions and product registrations/licensing.
• Develop the timeline for US‑FDA and international submissions based on the marketing and sales strategic plans.
• Work with colleagues to outline data submission requirements as required.
• As part of the Project Team, coordinate the collection of technical data to support submissions.
• Provide global regulatory strategies for new and modified products.
• Provide guidance on regulatory requirements for business partners and internal customers.
• Interface with executive management regarding applicable regulations and ensure regulatory compliance.
• Interface with all functional areas to advise on and assist with any compliance matters.
• Provide direction and guidance in the interpretation of the FDA Medical Device Reporting, UKCA, EU Medical Device Vigilance Reporting (and other markets as required) related to product incidents and potential adverse events.
• Company representative for all product/quality system regulatory agencies and Ministries of Health, to include FDA, European Notified Body, UKCA, ISO Registrar and Competent Authorities of the European Union. Remain current on regulatory requirements within these main markets.
• Maintain product technical files / technical documentation / declarations of conformity as required within the EU, UK, Australia, etc.
• Maintain registrations in foreign countries and ensure that shipments of products are not sent to non‑registered countries.
• Company representative for all quality system auditors regarding regulatory affairs compliance.
• Adhere to all workplace safety laws, regulations, standards and practices.
• Remain current and compliant with all training requirements.
• Note – this position is not responsible for compliance with import/export laws, tariffs, patents, intellectual property, REACH, RoHs, or fraud/abuse laws.

• Manage subordinate supervisors and employees in Regulatory Affairs.
• Be responsible for the overall direction, coordination, and evaluation of this functional area.
• Carry out supervisory responsibilities in accordance with organization's policies and applicable laws.
• Be responsible for interviewing, hiring, and training employees in regulatory affairs.
• Plan, assign, and direct work.
• Appraise performance, reward and discipline employees.
• Addressing complaints and resolving problems.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, successful candidates should thrive in a fast‑paced environment including rapidly evolving business needs.

The…