Key Areas of Responsibility:Assess links between global, societal, and economic trends; stakeholder concerns; and regulatory issues; and determine implications for regulatory strategy.Develop and update global, regional, and multi-country regulatory strategies, aligning them with organizational goals.Guide integration of regulatory considerations into global product entry and exit strategies.Identify regulatory pathways for initial product designs and provide input to internal stakeholders.Analyze proposed regulatory pathways and strategies, recommending changes based on initial regulatory outcomes.Assess requirements and obstacles for market access and distribution, developing solutions for anticipated challenges.Evaluate the impact of regulatory changes on pre- and post-approval strategies, adjusting approaches accordingly.Incorporate regulatory strategies to expedite development for products addressing serious or unmet medical needs.Negotiate with regulatory authorities throughout the product lifecycle.Establish and maintain relationships with government and non-government organizations affecting market access and distribution.Develop and manage new regulatory procedures and standard operating procedures.Train stakeholders on current and new regulatory requirements to ensure compliance.Provide strategic and technical guidance on global regulatory requirements during product development.Evaluate risks related to product and clinical safety during clinical phases and recommend solutions.Assess proposed changes for regulatory filing and plan for changes not requiring submissions.Review proposals to regulatory authorities on pathways and clinical plans.Monitor regulatory strategy implementation concerning safety issues during clinical phases.Provide expertise on preapproval inspections, GCP inspections, and clinical investigator relationships.Guide regulatory strategy for product claims and labeling.Ensure clinical and nonclinical data support proposed claims and meet regulatory requirements.Ensure policies are in place for internal review and approval of submissions.Lead negotiations and interactions with regulatory authorities during all development stages.Prepare teams for interactions with regulatory bodies, including advisory committees.Manage daily regulatory processes to evaluate issues effectively.Establish budgets and forecasts, making necessary adjustments with management input.Collaborate with QA, R&D, Supply Chain, Finance, Sales, and Marketing to meet corporate goals.Serve as Subject Matter Expert on regulatory processes.Provide guidance on new regulatory requirements and ensure organizational compliance.Establish processes for resolution and management of regulatory tasks.Lead meetings to resolve regulatory issues.Manage and report on regulatory metrics, implementing improvements as needed.Represent regulatory functions during audits.Set performance targets and manage team members to meet or exceed them.Recruit, onboard, and develop talent within the team.Maintain high team engagement and address performance issues proactively.Participate in strategic advocacy activities.Education / Work Experience:Bachelor's degree in science, engineering, or related field; advanced degree preferred.Minimum of 8 years of experience.Master's Degree or equivalent preferred.RAC certification desired.Experience in people management required.Knowledge / Competencies:Strong knowledge of regulatory requirements, including ISO, FDA, and international standards.Technical knowledge of medical device product lines.Excellent communication, listening, and team-building skills.Proven ability to lead cross-functional teams and collaborate effectively.Experience managing multiple projects and reporting trends and analysis.Leadership skills and process improvement expertise.Experience with recruiting and developing staff.Ability to influence organizationally.
#J-18808-Ljbffr