Regulatory Compliance Officer – Infusion Systems – Salt Lake City, UT

Regulatory Compliance Officer – Infusion Systems – Salt Lake City, UT

We are seeking a highly skilled Regulatory Compliance Officer to join our team in Salt Lake City, UT, overseeing regulatory requirements for infusion systems. This critical role demands an individual with deep knowledge of regulatory frameworks, ensuring that our products meet all compliance standards in a highly regulated medical field. If you are passionate about ensuring safety and regulatory adherence while working in a cutting-edge industry, this is the opportunity for you.

Lead Regulatory Compliance in a Dynamic Industry

Join a leading company in the infusion systems space, based in Salt Lake City, UT, as a Regulatory Compliance Officer. In this role, you will be responsible for managing all regulatory processes, preparing for audits, and ensuring that our infusion systems comply with both domestic and international regulations. The ideal candidate will possess in-depth experience in regulatory affairs within the medical device industry, and be a strategic partner in advancing product development in line with stringent regulatory standards.

Key Responsibilities of the Regulatory Compliance Officer – Infusion Systems

Regulatory Oversight & Compliance: Ensure all infusion systems meet regulatory standards, including FDA and international regulations. Oversee the preparation, submission, and management of regulatory filings and approvals to guarantee compliance throughout the product lifecycle.

Regulatory Strategy Development: Develop and implement regulatory strategies that align with business goals and regulatory requirements. Work closely with product development teams to ensure new and existing products meet regulatory standards in various markets.

Audit & Inspection Management: Lead and manage regulatory audits and inspections, both internal and external. Ensure readiness for regulatory inspections and prepare responses to regulatory inquiries or findings.

Risk Management & Mitigation: Proactively identify regulatory risks and provide strategies for mitigating these risks. Ensure that compliance-related issues are addressed promptly, maintaining product safety and quality while minimizing business disruptions.

Product Labeling & Documentation: Ensure that all product labeling, documentation, and marketing materials comply with regulatory requirements. Work with legal and marketing teams to review and approve product claims and representations.

Cross-Functional Collaboration: Collaborate with R&D, quality assurance, manufacturing, and legal teams to ensure that compliance is integrated into all stages of product development and manufacturing. Foster a culture of compliance within the organization.

Regulatory Training & Education: Develop and implement training programs to ensure all employees understand and adhere to relevant regulatory requirements. Provide ongoing education to ensure the organization stays current with regulatory changes.

Market Surveillance & Post-Market Compliance: Oversee post-market surveillance activities, including adverse event reporting, complaint handling, and corrective actions. Ensure that the company stays compliant with ongoing regulatory requirements after product release.

Stakeholder Communication: Serve as the key point of contact for regulatory bodies and internal stakeholders. Provide regular updates on regulatory compliance status, potential issues, and resolutions to senior management and external partners.

Continuous Improvement & Industry Knowledge: Stay current on regulatory changes, industry trends, and best practices. Ensure the company maintains high standards of compliance through continuous improvement efforts and the adoption of best practices in the regulatory field.

What the Client is Looking for in You

Proven Expertise in Regulatory Affairs for Medical Devices

The client is seeking a highly qualified Regulatory Compliance Officer with a deep understanding of regulatory requirements in the medical device industry, specifically in infusion systems. You should be a seasoned professional with a proven track record of navigating complex regulatory landscapes, ensuring that products meet all compliance standards from development through commercialization.

Experience in Infusion Systems and Medical Devices

The ideal candidate will have hands-on experience in regulatory affairs related to infusion systems or similar medical devices. You should be familiar with FDA regulations, ISO standards, and other relevant global regulatory frameworks. Experience in managing product registrations, submissions, and audits is crucial for success in this role.

Strategic Thinker with a Compliance-First Approach

As the Regulatory Compliance Officer, you will need to craft and implement regulatory strategies that align with both business objectives and industry regulations. The client values professionals who can anticipate regulatory changes, stay ahead of compliance challenges, and ensure that the company is well-positioned for market success while maintaining regulatory integrity.

Attention to Detail and Risk Mitigation Expertise

The client is looking for an individual who excels in identifying, managing, and mitigating regulatory and compliance risks. You should possess strong analytical skills and an ability to assess potential risks across all phases of product development and life cycle, ensuring that issues are addressed proactively and efficiently.

Collaboration and Cross-Functional Leadership

The Regulatory Compliance Officer must collaborate effectively with various teams, including product development, quality assurance, legal, and manufacturing. The client values a professional who can lead cross-functional initiatives and communicate regulatory requirements clearly, ensuring compliance throughout the organization.

Strong Communication Skills and Stakeholder Management

Effective communication with internal stakeholders and regulatory bodies is key to this role. The client seeks an individual who can present complex regulatory information in an accessible and actionable manner, fostering transparency and building strong relationships with regulatory agencies, senior leadership, and cross-functional teams.

Commitment to Continuous Learning and Regulatory Excellence

The client is looking for a Regulatory Compliance Officer who stays current with industry trends, regulatory changes, and best practices. A commitment to professional development and continuous improvement is essential to help the company maintain high compliance standards and operate effectively in the ever-evolving healthcare landscape.

FAQs About the Role – Regulatory Compliance Officer – Infusion Systems

1. What are the key responsibilities of the Regulatory Compliance Officer in this role?

As the Regulatory Compliance Officer, you will oversee the regulatory aspects of infusion systems, ensuring compliance with all relevant domestic and international regulations. Your responsibilities will include preparing regulatory submissions, managing audits and inspections, mitigating compliance risks, and ensuring that all product documentation is accurate and meets regulatory standards. You will also collaborate with cross-functional teams to integrate compliance throughout the product development and manufacturing processes.

2. What qualifications and experience are required for this position?

The ideal candidate should have a strong background in regulatory affairs, with extensive experience in the medical device industry, particularly in infusion systems or related fields. You should have a deep understanding of FDA regulations, ISO standards, and other global regulatory frameworks. A degree in life sciences, engineering, or a related field is required, and certification in regulatory affairs (such as RAC) is preferred. Prior experience in handling regulatory filings, audits, and post-market surveillance is also essential.

3. What skills and qualities are important for success in this role?

Success in this role requires a keen eye for detail, strong analytical skills, and the ability to manage multiple complex regulatory processes simultaneously. You should have excellent communication skills to interact with regulatory bodies, cross-functional teams, and senior leadership. A proactive approach to risk management and the ability to stay ahead of regulatory changes is crucial. The ability to navigate challenging compliance issues with a solutions-oriented mindset is key to thriving in this role.

4. What challenges can I expect in this role?

As the Regulatory Compliance Officer, you will face challenges related to changing regulatory environments, ensuring global compliance, and managing complex audits and inspections. Balancing regulatory requirements with product development timelines and maintaining product quality while ensuring compliance will require strong problem-solving abilities. The role also requires staying up-to-date with evolving regulations and mitigating any potential compliance risks that could impact product release or market access.

5. What is the expected impact of the Regulatory Compliance Officer on the company’s success?

The Regulatory Compliance Officer plays a critical role in ensuring that the company’s products meet regulatory standards, which is crucial for gaining market access and maintaining customer trust. Your work in managing compliance will directly impact the company’s ability to launch products on time, maintain safety standards, and avoid legal or financial penalties. Ensuring continuous compliance will also help the company maintain a positive reputation in the medical device industry.

6. What is the company’s culture and work environment like?

The company fosters a collaborative, compliance-driven culture that values precision, attention to detail, and teamwork. You will be working in a fast-paced environment with cross-functional teams, including product development, legal, and quality assurance. The company places a strong emphasis on continuous learning, innovation, and maintaining high standards of regulatory excellence, ensuring that employees have the support and resources they need to thrive in their roles.

What Remuneration Can You Expect from This Job?

As the Regulatory Compliance Officer for Infusion Systems in Salt Lake City, UT, you can expect a competitive and comprehensive compensation package that reflects the level of responsibility and expertise required for the role. The remuneration for this position typically includes:

1. Base Salary

The base salary for a Regulatory Compliance Officer in the medical device industry varies depending on experience, company size, and location. For this role, the annual base salary typically ranges from $90,000 to $150,000, with opportunities for higher compensation in larger or more complex organizations.

2. Performance-Based Bonuses

In addition to the base salary, most Regulatory Compliance Officer roles include annual performance-based bonuses. These bonuses are often tied to key performance indicators such as successful product registrations, regulatory approvals, and audit performance. Bonus potential can range from 10% to 30% of the base salary, depending on individual and company performance.

3. Equity & Stock Options

For senior-level roles, including regulatory affairs positions, some companies offer equity-based incentives such as stock options or restricted stock units (RSUs). These incentives help align your compensation with the long-term success of the company, offering significant financial rewards based on the company’s performance and growth.

4. Profit-Sharing & Long-Term Incentive Plans (LTIPs)

Some organizations may provide profit-sharing or long-term incentive plans (LTIPs) that reward sustained performance over several years. These programs encourage long-term growth and stability within the company, offering additional financial incentives based on company success, particularly in product innovation and market compliance.

5. Executive Benefits & Perks

As a Regulatory Compliance Officer, you will receive comprehensive benefits, including:

• Health, dental, and vision insurance
• 401(k) or pension plans with company contributions
• Executive retirement plans
• Travel allowances or company-provided vehicles
• Wellness programs to support your health and well-being
• Expense accounts for business-related activities and professional development

6. Signing Bonuses & Relocation Assistance

For highly qualified candidates, companies may offer signing bonuses or relocation packages to help ease the transition into the role. These one-time incentives can range from $5,000 to $50,000, depending on the company and the candidate’s experience.

Total Compensation Potential

When factoring in base salary, performance bonuses, stock options, and other benefits, the total compensation for a Regulatory Compliance Officer in the medical device industry can range from $100,000 to $200,000 annually. In larger companies or roles with significant responsibilities, the total compensation package can exceed $250,000.

How to Apply

If you are a regulatory expert with experience in the medical device industry, particularly in infusion systems, we invite you to apply for the Regulatory Compliance Officer – Infusion Systems role in Salt Lake City, UT. This is a great opportunity to play a key role in ensuring compliance with global regulatory standards and contributing to the success of a growing medical device company.

To apply, please submit your resume along with a cover letter detailing your experience in regulatory affairs, particularly in the medical device sector. Highlight your knowledge of FDA regulations, ISO standards, and your ability to manage regulatory submissions, audits, and compliance risks. We are looking for someone who can integrate regulatory requirements seamlessly into product development processes and drive compliance initiatives across the organization.

This role offers an impactful career opportunity where you will directly contribute to the company’s ability to bring safe and compliant products to market. Apply today to join a team that values regulatory excellence and continuous improvement!

For more information or to explore similar opportunities, visit our Regulatory Affairs Career Page.

Tags: Regulatory Compliance Officer | Medical Device Jobs | Infusion Systems Regulatory Affairs | FDA Regulations | ISO Standards | Risk Management | Medical Device Compliance | Regulatory Affairs Careers