Senior Director Regulatory Affairs

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Senior Director, Regulatory Affairs
Duties: Identify and develop new regulatory policies, processes and SOPs. Provide current regulatory intelligence and formulate regulatory strategies. Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution. Oversee implementation of regulatory strategy and activities needed to secure approval of new products, including in vitro diagnostics and medical devices. Activities include, but are not limited to, coordination of submissions, preparation of responses to regulatory authorities and auditors, lead meetings with regulatory authorities, and lead panel meetings. Serve as a principal interface with reviewers and auditors from the FDA and other health authorities (e.g. Notified Bodies, National/Regional competent authorities, etc.). Provide regulatory advice to other functional areas. Identify perceived gaps in product development plans that may pose regulatory issues. Develop and maintain relationships with external vendors and regulatory authorities to improve effectiveness in regulatory strategy execution. Oversee regulatory authority inspections and provide input for follow-up to inspections and audits to minimize potential for findings of noncompliance. Oversee activities related to post-market surveillance. Oversee activities related to product recall and recall communication process. Assure medical device reports (MDR) are reported to regulatory agencies and internal stakeholders. Manage processes involved with maintaining annual licenses, registrations and listings. Ensure compliance with product post-marketing approval requirements. Oversee advertising and promotional review to ensure regulatory compliance. Update department personnel, departments and business units on the current regulatory environment, new regulations and enforcement actions as relevant to the business. Work with cross functional leadership to assure appropriate project prioritization and resource allocation. Develop annual regulatory plan and budget per corporate and business unit priorities. Lead employees, consultants/contractors in Regulatory Affairs. Optimize employee performance by mentoring and developing employees to sustain resource base for evolving business needs. Develop and implement operating guidelines and common work practices/strategies within the team. Communicate goals clearly to employees to ensure understanding and success in achieving them. Motivate and inspire employees to do their best work through coaching. Maintain morale and support employee engagement initiatives.

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