Job Description:

Provide regulatory support for neurostimulation therapy for the treatment of obstructive sleep apnea in adult and pediatric patients. Focus on US and international regulatory submissions and evaluate market access requirements for new geographies in Asia and Latin America, e.g., India, Brazil, and others as required. Conduct regulatory assessments of design and manufacturing changes, e.g. engineering change orders and supplier change requests. Assist with manufacturing and design changes and new product development submissions, as well as conducting gap assessments between Inspire’s US and EU regulatory documentation and the regulatory requirements in new geographies.  Interact directly with regulatory agencies at the reviewer level. Review labeling and promotional material for regulatory compliance. Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.

Job Requirements:

1. Bachelor’s degree in engineering, pharmacy, or relevant scientific field.
2. Five (5) years of progressive experience in Regulatory Affairs or a related discipline in the medical device industry.
3. Two (2) years of experience specifically in Regulatory Affairs, which may have been gained as part of or in addition to the required progressive experience.
4. Experience must include:
   1. US Class III devices.
   2. Authoring a variety of regulatory submissions for US and EU related to implantable devices.
   3. Basic submission processing experience with submission portal use and fee processing systems
   4. Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
5. Must have current authorization to be employed in the U.S. without employer sponsorship.

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Position Summary:

Main Duties/Responsibilities:

• Project Management: Coordinate with the Academic Development Team & Sales organization regarding our Fellowship program which includes scheduling meetings, introductions, and other details.
• Project Management: Coordinate with Medical Education team regarding our Advanced Practice Provider (APP) Education Programs and other Medical Education programs that support the Inspire therapy. 
• Coordinate and participate in Residents and Fellows video series for continued learning.
• Data Management: Update data in Microsoft Dynamics working externally with Academic Centers to do so. 

Educational Requirements:

• Currently pursuing a four-year degree in Business, Marketing, Data Management, or a related field

Required Experience: 

• Strong attention to detail and organizational skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong communication skills, both verbal and written.
• Ability to work independently and collaboratively.
• Willingness to take initiative and seek solutions.

Preferred Experience:

• Experience with Microsoft Dynamics and Smartsheets
• Experience working with remote teams or field-based professionals.

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Account Supervisor, Technology 

As an Account Supervisor you will be responsible for the planning and implementation of B2B programs on our technology team working with industrial tech, construction and food tech companies. You’ll help manage work executed by account executives, assistant account executives and interns. This position will work closely with clients, take a more advanced role in the preparation of communication plans, and is expected to consistently deliver superior results.

We’re looking for someone who has a love of writing, telling complex stories and bringing them to life through paid, earned, shared and owned communications channels.

WHAT YOU’LL BE DOING:

• Client Engagement - Demonstrating above-average teamwork and relationship-building skills, along with client counseling and client leadership skills as you participate and lead client meetings.
• Marketing Communications - Developing and executing marketing communications programs for technology and manufacturing clients to help them build, grow, and protect their brands.
• Writing – Digging deep into industry trends and client needs to develop content such as messaging, news releases, bylined articles, social media content, sales enablement tools, e-books and more.
• Strategic Thinking – Work with senior leaders to assess client needs and develop recommendations on best approaches for reaching key audiences, which may include creation of annual plans, content strategy, media strategy.
• Media Relations - Managing and executing media relations programs, including strategy and story development, prioritizing target media, facilitating media briefings, developing talking points, and briefing notes for spokespeople and reporting on results.
• Collaborating – Whether it’s across the Padilla Tech team, a Padilla committee or one of the 3-5 client teams you’ll support, collaboration is a big part of everything we do! As an AS you’ll also have a chance to mentor interns, AAEs and/or AEs about the craft of communication and your clients’ business/industry.
• Growing Professionally – Many people on our team have worked at Padilla for 10+ years in large part because there is always an opportunity to learn and apply new things. If you like to dig into the latest communications tools and trends, this is the place for you!
• New Business Development – You’ll have an opportunity to support Padilla business development efforts through marketing, networking, identifying prospective clients and participating in new business pitches.
• Traveling – Some travel, as needed, for client meetings and/or media/special events
• Other duties and responsibilities as assigned

WHAT WE’RE LOOKING FOR:

• Bachelor’s degree or equivalent industry experience
• Six or more years of experience in communications/public relations; agency experience is preferred
• An interest in technology
• Strong verbal and written communication skills
• A strategic and curious collaborator with demonstrated desire for continuous learning

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The Vice President of Finance will lead financial operations, governance, and strategic financial planning for AVENIR GLOBAL’s US operations and affiliated agency brands. This senior leadership role is responsible for ensuring financial integrity, enabling strategic decision-making, and supporting profitable growth while maintaining strong internal controls. The role serves as a key strategic advisor to agency Managing Directors/Partners and operational leadership while ensuring alignment with corporate finance standards, reporting frameworks, and governance requirements across the global organization.

The VP of Finance will oversee financial reporting, planning and analysis, compliance, internal controls, and finance operations across US entities, while contributing to broader corporate finance initiatives including financial transformation, process standardization, and global reporting integration. The role carries responsibility for financial oversight and performance management of US agency P&L operations. This position also includes responsibility for financial governance related to employee benefit programs, including fiduciary oversight of the company’s 401(k) retirement plan, ensuring compliance with ERISA regulations and supporting annual plan audits.

KEY OBJECTIVES

Strategic Financial Leadership

• Provide financial leadership for AVENIR GLOBAL’s US agency operations aligned with corporate strategy and group financial objectives. Support long-term growth by evaluating business performance, identifying opportunities for operational efficiency, and mitigating financial risk.
• Serve as a trusted financial advisor to agency leadership and corporate executives regarding commercial strategy, pricing models, investments, and operational planning. Ensure transparency and accuracy in financial reporting across all areas of responsibility.

Financial Operations, Reporting & Corporate Alignment 

• Oversee all financial operations across US agency entities, including accounting, financial planning and analysis, reporting, and financial controls. Ensure financial processes, reporting frameworks, and governance practices are aligned with AVENIR GLOBAL corporate standards.
• Ensure timely and accurate reporting for both US leadership and corporate finance, supporting group consolidation requirements.
• Maintain a strong financial control environment and ensure compliance with US GAAP and applicable regulatory requirements.

Finance Team Leadership

• Lead and develop a high-performing finance team supporting multiple agency brands.
• Establish clear responsibilities, efficient workflows, and consistent reporting standards across finance functions.
• Promote a culture of accountability, collaboration, and continuous improvement within the finance organization.

KEY RESPONSIBILITIES

Financial Strategy & Planning

• Develop and execute financial strategy for US agency operations aligned with AVENIR GLOBAL corporate objectives.
• Lead the annual budgeting process and rolling quarterly forecasts for US entities.
• Provide financial modeling and scenario analysis to support strategic initiatives including:
  • Agency growth initiatives
  • New service offerings
  • Workforce expansion
  • Cost optimization
  • Strategic investments or acquisitions
• Evaluate capital allocation decisions and investment cases for business initiatives.
• Support agency leadership in driving financial performance and profitability.

Financial Reporting & Analysis

• Oversee preparation of monthly, quarterly, and annual financial statements for US entities. Ensure delivery of consolidated reporting packages including reconciliations, variance analysis, and performance commentary.
• Analyze financial performance across agency brands to identify trends, risks, and opportunities.
• Develop management reporting that supports business insights including:
  • Revenue performance
  • Client profitability
  • Utilization and productivity
  • Margin performance
  • Overhead management
• Present financial performance updates to US executive leadership and corporate finance.

Business Partnership

• Partner closely with Managing Directors/Partners, agency leadership teams, and operational leaders to support commercial decision-making.
• Provide financial oversight and guidance for pricing strategy, client contracts, and new business proposals. Support revenue assurance initiatives to ensure accurate billing and strong cash collection practices.
• Collaborate with operations and HR leadership on workforce planning, utilization forecasting, and compensation cost management.

Financial Control, Governance & Compliance

• Maintain a strong internal control environment across all US financial processes.
• Ensure compliance with US GAAP, federal and state tax requirements, and regulatory obligations.
• Oversee annual external audits and coordinate with auditors, tax advisors, and financial institutions. Safeguard company assets and ensure adherence to financial policies and governance frameworks.
• Support corporate internal audit and risk management initiatives where applicable.

401(k) Plan Governance and Fiduciary Oversight

• Serve as a fiduciary representative for the company’s 401(k) retirement plan, ensuring compliance with ERISA regulations and Department of Labor requirements. Oversee administration and financial governance of the plan in collaboration with HR, plan administrators, and external advisors.
• Coordinate and support annual 401(k) plan audits, including preparation of financial documentation and audit schedules. Ensure compliance with annual retirement plan nondiscrimination testing requirements, including ADP/ACP and highly compensated employee testing.
• Ensure timely correction of any testing failures or compliance issues and monitor plan service providers to ensure fiduciary responsibilities are fulfilled in the best interest of plan participants. Support employee education initiatives related to retirement plan participation and compliance. Ensure accurate reporting for Form 5500 filings and related regulatory documentation.

Team Leadership & Development

• Lead, mentor, and develop finance team members across accounting, FP&A, and finance operations.
• Recruit and develop finance professionals to support organizational growth. Oversee performance reviews, goal setting, and professional development planning. Promote best practices in financial management and process improvement.

Systems, Process Improvements & Global Collaboration

• Drive improvements in financial systems, automation, and reporting processes. Improve efficiency in budgeting, forecasting, month-end close, and financial reporting. Partner with corporate finance and IT on financial system implementations and upgrades. Leverage financial analytics to improve decision-making and operational visibility.
• Participate in global finance initiatives including:
  • Finance transformation
  • System upgrades
  • Process standardization
  • Global reporting alignment

AI Adoption, Governance & Responsible Use

• Lead the adoption and responsible use of artificial intelligence tools within the finance function and support broader AI adoption across US agency operations.
  • Lead responsible AI adoption
  • Improve financial analytics and forecasting
  • Ensure governance and data protection
  • Support training and adoption across agencies

QUALIFICATIONS

Essential

• Bachelor’s degree in Finance, Accounting, or related field.
• CPA or equivalent professional designation preferred.
• Extensive senior finance leadership experience within professional services environments (agency, consulting, communications, legal, or similar).
• Strong knowledge of US GAAP, financial controls, taxation, and audit processes.
• Experience managing complex, multi-entity financial reporting environments.
• Advanced financial modeling and Excel skills.
• Experience working with modern ERP or financial systems.
• Demonstrated ability to translate financial data into actionable business insights.
• Strong executive stakeholder management skills.

Preferred

• Experience working within private equity-backed or holding company structures.
• Experience supporting global or multi-country finance operations.
• Experience leading finance transformation or system implementation initiatives.
• Experience supporting employee benefit plan governance including 401(k) compliance and audits.

Key Competencies

• Strong commercial acumen and analytical mindset.
• Strategic thinker with the ability to operate at both executive and operational levels.
• High integrity, discretion, and commitment to financial governance.
• Excellent communication and presentation skills.
• Collaborative leadership style with the ability to influence across agency brands and corporate leadership.
• Comfortable operating in fast-paced, deadline-driven environment 

*Minimal travel required. 

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• Serve as a strategic regulatory partner to product development, operations, quality, clinical, manufacturing, and marketing teams, providing clear guidance on regulatory requirements and risks.
• Independently assess regulatory impact for new product development and post-market product changes, including design, manufacturing, labeling, and supplier changes. 
• Develop and communicate regulatory pathway options and recommendations aligned with business objectives and global regulatory expectations.
• Compile, prepare, review, and submit high-quality regulatory submissions in the U.S. for PMA, IDE, supplements, and amendments, and EU for MDR Class III Technical Documentation, design change, notified body responses.
• Collaborate with subject matter experts to prepare accurate, timely, and professional responses to regulatory authority questions.
• Review and approve product development, operations, labeling, clinical, and software documentation to ensure regulatory compliance and submission readiness.
• Maintain accurate regulatory files, submissions, and tracking systems across the product lifecycle.
• Manage multiple projects simultaneously, maintaining high attention to detail, accountability, and execution quality.

• Complete all required training and maintain competency for assigned responsibilities. 
• Comply with applicable Quality System procedures and regulatory requirements. 
• Identify opportunities for continuous improvement in regulatory processes, tools, and documentation practices.

• Bachelor’s degree in engineering, life sciences, or related scientific discipline (or equivalent experience)

• 5+ years of experience in a regulated industry with transferable skills to medical devices. 
• Strong technical writing, communication, and stakeholder‐management skills.
• Demonstrated ability to work independently on regulatory assessments and submissions.

• Medical device industry experience, in regulatory affairs, quality, and/or engineering.
• Direct experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA supplements, Pre-submissions, EU Technical Documentation and NB interactions.
• Experience interacting directly with regulatory authorities. e.g., FDA, Notified Bodies, or Competent Authorities. 
• Regulatory support experience in one or more of the following areas:
  • Active implantable medical devices
  • Software regulated as a medical device or software as part of a medical device
  • Manufacturing or supplier changes
• Working knowledge of applicable regulations and standards:
  • 21 CFR Part 11, 820, 814
  • EU MDR (EU) 2017/745
  • ISO 13485, ISO 14971
  • IEC 60601, IEC 62304, IEC 62366
  • ISO 10993

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