Regulatory Science & Policy Director

Job Description

The Regulatory Science & Policy Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their potential impacts on products and services.

Your role:

• Guides the analysis of global regulatory requirements and industry standards to identify their potential impacts on products and services, conducting thorough evaluations and providing strategic recommendations to ensure proactive adaptation to regulatory changes and minimizing compliance risks.
• Develops & facilitates comprehensive product compliance strategies that align with risk and compliance domains, ensuring these strategies are integrated into business processes and consistently adhered to across the organization.
• Participates in regulatory discussions actively to shape favorable regulatory environments and maintain strong relationships with regulatory authorities, coordinating with regulatory bodies, industry organizations, and key stakeholders to influence policy development and advocate for interests.
• Monitors changes in global applicable regulations and standards by actively engaging with regulatory bodies and industry groups, communicating relevant updates to internal stakeholders through detailed reports and presentations, may be responsible to conduct reviews and provide feedback on regulatory aspects of product development and marketing plans, ensuring alignment with global regulatory requirements, offering strategic input during product design and development phases to preemptively address potential regulatory challenges.
• Optimizes regulatory processes and workflows by identifying inefficiencies and implementing improvements to enhance operational efficiency and effectiveness in compliance activities, leveraging industry best practices and technological advancements to streamline regulatory processes.
• Utilizes advanced knowledge of global applicable regulations to resolve complex regulatory challenges, working closely with product teams to ensure products meet all necessary standards for market approval, providing expert guidance on regulatory strategy and compliance to support successful product launches and market expansions.
• Builds and maintains effective relationships with internal and external stakeholders, including regulatory bodies, industry groups, and cross-functional teams, facilitating open communication and collaboration to ensure regulatory compliance efforts are well-coordinated and supported.
• Ensures implementation of policies and procedures to drive continuous improvement initiatives that enhance compliance, efficiency, and organizational effectiveness, ensuring alignment with risk and compliance domains and industry best practices.

You're the right fit if:

• You’ve acquired a minimum of 10+ years’ experience in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical Device/Technology industry or Health Authority (FDA), with proven experience in Strategic Regulatory program leadership.
• You have a demonstrable history of success in a regulatory or health policy role, strong understanding of regulatory and legislative environments, with strong experience building/fostering strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Health Authorities).
• You have proven experience in preparing/delivering training sessions and informational materials to internal teams on regulatory compliance topics, fostering a culture of continuous learning and adherence to standards and ensuring that all employees are well-informed about regulatory requirements and their roles in maintaining compliance.
• You have extensive experience in planning in-depth research on regulatory issues and trends, synthesizing findings into actionable insights, mentoring junior regulatory associates, and optimizing regulatory processes and workflows.
• You have a minimum of a Bachelor’s degree (required); Master’s or Advanced degree-JD, Regulatory Science (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than apart. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

Transparency Details:

• The pay range for this position in Washington, DC is $172,200 to $275,520.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At , it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Washington, DC.
• May travel up to 10%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.