Director Regulatory Policy & Intelligence Americas

Work Flexibility: Remote

Key Areas of Responsibility:

• Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence

• Recognized as thought leader in advocacy activities

• Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes

• Accesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategy

• Integrates regulatory considerations into the organization's global product entry and exit strategy

• Identifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical products

• Manages negotiations with regulatory authorities on complex issues throughout the product lifecycle

• Influences changing regulations and guidance

• Interfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distribution

• Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs

• Leads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycle

• Leads the development and execution of good regulatory practices and policy

• Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products

• Leads the regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during preapproval/clinical phases

• Participates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessment

• Approves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changes

• Reviews and approves publicly disseminated information on product submission approval status

• Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets

• Implement regulatory system changes to support evolving regulations and international standards

• Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities

• Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission

• Establish standard process to ensure appropriate resolution and management of the responsible task owner

• Chair meetings required to drive closure of regulatory issues

• Manage and provide updates for regulatory metrics. Implement appropriate enhancements

• Represent regulatory processes during internal and external audits

• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets

• Recruit, select, and on-board top talent

• Develop talent within team to increase performance. Actively address performance issues on team

• Maintain a high level of team engagement

• Participate in advocacy activities of a more advanced strategic nature

Education / Work Experience:

• BS in Engineering or other relevant field of study

• Minimum of 10 years’ experience

• Master's Degree or equivalent preferred

• RAC desired

Knowledge / Competencies:

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements

• Demonstrated expertise in regulatory systems in a regulated environment

• Demonstrated project management skills

• Demonstrated verbal, written, and interpersonal communication skills

• Demonstrated ability to work in a team environment, interact effectively with management from other functions

• Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets

• Demonstrated ability to initiate work

• Demonstrated analytical ability

• Demonstrated ability to make effective decisions

• Experience with recruiting, people development

• Influence across the organization

Compensation:

• $149,300- $329,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.