Job Description

Kelly® Science & Clinical is seeking a hybrid Director, Regulatory Affairs for a direct hire position at a leading client in Valencia, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

Up to: $205,000/Year (commensurate with experience)

Overview:

As the Director, Regulatory Affairs, Regulatory Operations and North America for Advanced Bionics, you will play a critical leadership role in guiding the regulatory team in navigating complex regulatory landscapes and ensuring compliance with all applicable regulations of active implantable medical devices. Your expertise will contribute to creating and executing successful strategies for regulatory submissions, ensuring on time product approvals.

Schedule:

• Monday – Friday, 1st/Day: Standard Hours

• Hybrid: 3 Days Onsite, 2 Days remote

Responsibilities:

Key Responsibilities:

• Regulatory Strategy: Develop and implement comprehensive regulatory strategies to support the development, approval, and marketing of Class III medical devices primarily in the US and Canada.

• Compliance Oversight: Ensure that the company's products comply with regulatory standards (FDA, EU MDR, and other international regulations) throughout the product lifecycle.

• Submissions & Approvals: Lead the preparation, submission, and maintenance of regulatory filings for the US and Canada. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e., IDE) for conducting clinical investigations. Generate/Oversee required submissions (progress reports, etc.) to support the continuation of clinical studies.

• Team Leadership: Manage and mentor a team of regulatory professionals, fostering professional growth and promoting a high-performance culture. Includes providing strategic leadership and guidance to RA team members embedded in project core teams, ensuring they effectively represent global regulatory requirements, manage timelines for submissions and approvals, and collaborate cross-functionally to support product development any necessary post-approval design changes. In addition is responsible for ensuring compliance with all employment regulations, requirements and performance expectations. This includes the development of direct reports and team members through the use of Performance Objectives, training and development plans, Performance Appraisals, merit processes and Performance Management Plans to ensure success of the team.

• Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Marketing, and Manufacturing teams to align regulatory strategies with business objectives.

• Risk Management: Develop risk mitigation strategies related to regulatory compliance, audits, and product approvals. Lead responses to regulatory inquiries and inspection readiness activities.

• Product Labeling: Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and maintenance of all product labeling according to relevant standards and country specific requirements.

• Regulation & Standards Compliance: Leads the process for ensuring comprehensive compliance framework for assessing and integrating external standards and regulatory changes, ensuring alignment across cross-functional teams and driving proactive procedural updates.

• Stakeholder Management: Act as the primary liaison with regulatory authorities, managing relationships and communications with agencies such as the FDA, Notified Bodies, and Health Canada.

• Change Management: Stay abreast of evolving global regulatory requirements and implement changes within the organization as needed, ensuring continuous compliance.

Additional Key Responsibilities:

• Oversees any field corrective actions.

• Supports management with implementation of departmental strategies and company policies.

• Collaborates with cross functional teams to resolve complex project issues.

• Effectively plans and organizes team’s work to ensure company objectives are met.

• Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business priorities.

• Supports regulatory agency audits, as required.

• Contributes to the development or the RA budget by forecasting resource needs, estimating costs for submissions, recertifications and compliance activities and aligning financial planning the strategic regulatory objectives.

• Once budget is set, manages within plan and escalates if/when issues arise.

• Other duties as assigned.

Travelling Requirement:

• Up to 10%.

Qualifications:

Basic Education:

• Bachelor’s Degree in Regulatory Affairs or scientific discipline required.

• Advanced Degree in Regulatory Affairs preferred (not required).

Further Education:

• RA certification (by Regulatory Affairs Professional Society) preferred (not required).

• Coursework, seminars, and/or other formal trade association training required.

Work Experience:

• Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance).

• 8+ years of progressive management experience.

• 5+ years of experience working with business stakeholders within a cross-functional matrix environment.

• 5+ years Class III Medical Device Company in Regulatory Affairs.

• Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle.

• Desirable industry background includes battery operated electromechanical systems and/or wireless technology.

• Experience managing a globally diverse, remote team.

Personal Competencies:

• Excellent interpersonal, communication (oral and written), teamwork, leadership, organizational and negotiating skills.

• Writes in a clear, concise, organized and convincing manner for the intended audience.

• Solid critical analytical and problem-solving skills, including consistent and effective problem solving.

Strategic Thinking:

• Capability to develop and implement regulatory strategies that align with organizational goals.

• Must be able to work with all levels of management have the ability to influence the actions of others to ensure compliance.

• Creates a positive environment within the team and for its customers.

Social Competencies:

• Builds and maintains constructive working relationships characterized by high level of acceptance, confidence, cooperation and mutual respect.

• Promotes cooperation within and outside of the team to achieve goals and deliverables.

• Ability to work under pressure and meet project timelines across departments.

Effective Communication:

• Ability to clearly and concisely convey information to diverse audiences, including regulatory bodies, internal and external stakeholders.

Leadership Competencies:

• Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the business.

• Proven ability to demonstrate drive for results and accountability of business needs.

• Strong mentorship skills.

• Flexible with proven ability to adjust to and lead a team through shifting priorities, demands and timelines.

Professional Competencies:

• Demonstrated experience in effectively directing teams and individuals to take action and meet organizational commitments.

• Manages resources efficiently to achieve timely, successful results.

• Coaches team, direct reports, and colleagues for communication, quality and trustworthiness.

• Manages and resolves conflicts, disagreements in a constructive manner.

• Ability to manage competing priorities in a fast-paced environment Influences, motivates, and challenges others.

What Happens Next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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