Director of Regulatory Affairs
EnergyHubSalary not specified
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
Requirements
- Based in Tempe, AZ with a hybrid work schedule of three days per week in office (relocation support provided)
- Ability to lead a team of 5 direct reports
- Expertise in developing national, regional, and global regulatory strategies
- Recognized thought leadership in advocacy activities
- Skills in accessing, interpreting, and synthesizing environmental scans, socioeconomic, scientific, and regulatory intelligence
- Experience integrating regulatory considerations into global product entry and exit strategies
- Proficiency in identifying early regulatory issues in development or research phases for complex/critical products
- Capability to manage negotiations with regulatory authorities on complex issues throughout the product lifecycle
- Ability to influence changing regulations and guidance
- Experience interfacing and building relationships with government and non-government organizations impacting market access and distribution
- Knowledge of good regulatory practices and policy development/execution
- Strategic input provision on regulatory requirements for R&D and clinical leads
- Leadership in evaluating risk and safety issues and recommending regulatory solutions
- Participation in risk-based decisions for compassionate use/special access approvals
- Authority to approve regulatory filing strategies, publicly disseminated information, and compliance requirements
- Experience implementing regulatory system changes and ensuring compliance with international standards and regulations
- Skills in providing strategic direction, tactical focus, chairing meetings, managing metrics, representing in audits, defining KPIs, recruiting, and developing talent
Responsibilities
- Develop and execute global regulatory strategy for Stryker Sustainability Solutions (SSS) business unit
- Partner with business unit leadership, Marketing, R&D, Clinical, and Quality teams
- Develop organization's national, regional, and global regulatory positions and strategies based on internal/external intelligence
- Serve as thought leader in advocacy activities
- Develop product positioning strategies for complex/critical products based on regulatory requirements and changes
- Integrate regulatory considerations into global product entry and exit strategy
- Identify issues early in development/research that impact regulatory strategy, submissions, or launches
- Manage negotiations with regulatory authorities on complex issues throughout product lifecycle
- Influence changing regulations and guidance
- Interface and establish relationships with government/non-government organizations for market access/distribution
- Lead efforts to incorporate regulatory strategies for expedited development of products for serious/life-threatening conditions or unmet needs
- Lead development and execution of good regulatory practices and policy
- Provide strategic input on regulatory requirements to R&D and clinical leads for complex/critical products
- Lead regulatory team's engagement in risk/safety issue evaluation and recommend solutions during preapproval/clinical phases
- Participate in risk-based decisions on compassionate use/special access approvals
- Approve regulatory filing strategies for complex/critical products based on changes
- Review and approve publicly disseminated information on product submission approval status
- Review regulatory compliance for changes affecting submissions and manufacturing globally
- Implement regulatory system changes for evolving regulations and standards
- Provide strategic direction and tactical focus to Regulatory Affairs organization and influence divisional activities
- Ensure pre-market submissions, registrations, and functions comply with standards/regulations
- Establish standard processes for resolution and management of regulatory issues
- Chair meetings to drive closure of regulatory issues
- Manage and update regulatory metrics; implement enhancements
- Represent regulatory processes in internal/external audits
- Define targets, KPIs, performance objectives for team; manage direct reports to meet/exceed them
- Recruit, select, and onboard top talent
- Develop talent within team to increase performance
Skills
Regulatory Strategy
Regulatory Advocacy
Product Positioning
Regulatory Intelligence
Negotiations
Market Access
Government Relations
Product Lifecycle Management
R&D Integration
Quality Assurance
Stryker
Develops and manufactures medical devices and equipment
About Stryker
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.
Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
