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# Imaging Device Regulatory Affairs Associate – Kansas City, MO


 
Imaging Device Regulatory Affairs Associate – Kansas City, MO
A leading organization in the medical device industry is seeking a highly skilled and motivated Imaging Device Regulatory Affairs Associate to join their team in Kansas City, MO. This is a unique opportunity to be part of a forward-thinking company that is committed to providing high-quality imaging solutions. If you have a deep understanding of regulatory requirements in the healthcare sector and are passionate about contributing to the advancement of imaging technology, this role is perfect for you.
Contribute to Regulatory Compliance and Innovation
As an Imaging Device Regulatory Affairs Associate, you will play a crucial role in ensuring the compliance of imaging devices with all relevant regulations and standards. You will collaborate with cross-functional teams to navigate the complex regulatory landscape and ensure timely market entry for innovative products. This is an exciting opportunity to work with cutting-edge technology while ensuring the safety and effectiveness of imaging devices in the healthcare industry. If you are ready to make a meaningful impact in the medical field, this position offers the perfect platform for professional growth and success.
Key Responsibilities of the Imaging Device Regulatory Affairs Associate – Kansas City, MO
Regulatory Compliance & Documentation: Ensure that all imaging devices meet relevant regulatory requirements, including FDA and international standards. Prepare, review, and submit regulatory filings such as 510(k), PMA, and CE Mark applications to facilitate market approval.
Regulatory Strategy & Market Access: Collaborate with cross-functional teams to develop and execute regulatory strategies for new and existing products. Provide guidance on regulatory pathways and ensure timely market access for innovative imaging devices.
Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Marketing, and Operations teams to ensure product designs meet regulatory standards. Provide regulatory input during the development process to ensure compliance from inception through commercialization.
Regulatory Submissions & Communication: Prepare and manage the preparation of regulatory submissions, including pre-market approval, product registration, and labeling requirements. Communicate with regulatory agencies and ensure timely responses to inquiries and requests.
Risk Assessment & Compliance Monitoring: Perform risk assessments to identify potential regulatory issues and provide solutions to mitigate risks. Monitor post-market activities to ensure ongoing compliance with regulatory requirements and ensure timely reporting of adverse events.
Regulatory Intelligence & Industry Trends: Stay informed about changing regulatory requirements and industry best practices. Analyze and interpret regulatory guidelines and communicate changes to relevant stakeholders to ensure ongoing compliance.
Documentation & Reporting: Maintain thorough documentation of regulatory processes, approvals, and communications with regulatory bodies. Prepare reports for senior management and regulatory bodies as needed to ensure transparent and accurate record-keeping.
Training & Education: Provide regulatory training to internal teams, ensuring understanding of compliance requirements and regulatory processes. Educate employees on the impact of regulations on product development, marketing, and distribution.
Continuous Improvement: Contribute to process improvements within the regulatory affairs department to enhance efficiency, effectiveness, and compliance. Identify opportunities for streamlining regulatory activities and reducing time to market for imaging devices.
What the Client is Looking for in You
Experienced Regulatory Affairs Professional in Imaging Devices
For the Imaging Device Regulatory Affairs Associate role, the client seeks an experienced and detail-oriented regulatory affairs professional with a deep understanding of the healthcare and medical device industries. You should be knowledgeable about global regulatory requirements, including FDA regulations and international standards, with a track record of ensuring compliance for medical devices, particularly imaging technologies.
Strong Knowledge of Regulatory Pathways
The ideal candidate should have extensive experience navigating the regulatory landscape for imaging devices. You must demonstrate the ability to develop and execute regulatory strategies for pre-market approval, product registration, and ongoing market access. Experience with 510(k), PMA, CE Mark, and other regulatory submissions is highly valued.
Strategic Problem-Solver with Attention to Detail
The client is looking for a proactive regulatory affairs professional who can identify regulatory challenges early in the product development cycle and work collaboratively with cross-functional teams to find effective solutions. You should be detail-oriented and meticulous in your documentation and regulatory submissions, ensuring accuracy and compliance at every stage.
Excellent Communication and Collaboration Skills
You must possess excellent written and verbal communication skills, as you will be required to interact with regulatory agencies, internal teams, and senior leadership. The ability to effectively communicate complex regulatory requirements and act as a liaison between teams is crucial to success in this role. Strong collaboration skills are essential for working closely with R&D, quality assurance, and product development teams.
Regulatory Intelligence and Industry Awareness
Staying updated with changing regulations and industry best practices is critical. The ideal candidate will demonstrate a passion for keeping up-to-date with the latest developments in medical device regulations and regulatory best practices. The ability to apply this knowledge to improve internal processes and reduce time to market for imaging devices will be a key asset.
Commitment to Compliance and Risk Management
The client values a candidate who understands the importance of compliance and risk management. You should have a solid understanding of risk assessment and mitigation strategies to ensure regulatory compliance while maintaining product quality. A focus on minimizing operational, financial, and reputational risks is a key requirement for this role.
Adaptability in a Fast-Paced Environment
The client is looking for someone who thrives in a fast-paced, dynamic environment. The ability to adapt to changing priorities, manage multiple projects simultaneously, and work under pressure to meet regulatory deadlines is essential for success in this role.
Commitment to Continuous Improvement
Finally, the client seeks a regulatory affairs professional who is dedicated to continuous improvement. You should be able to identify opportunities to streamline processes, enhance efficiency, and improve overall regulatory performance within the organization.
FAQs About the Role – Imaging Device Regulatory Affairs Associate – Kansas City, MO

What are the key responsibilities of the Imaging Device Regulatory Affairs Associate in this role?

As an Imaging Device Regulatory Affairs Associate, you will be responsible for ensuring regulatory compliance for imaging devices. Your duties will include preparing regulatory submissions (e.g., 510(k), PMA, CE Mark), managing interactions with regulatory bodies, and supporting cross-functional teams during product development. You will also monitor post-market compliance, manage risk assessments, and ensure timely approval for market entry, while keeping up-to-date with changing industry regulations.

What qualifications and experience are required for this position?

The ideal candidate should have a background in regulatory affairs, with experience in the medical device or healthcare industry, particularly in imaging devices. A thorough understanding of FDA regulations and international standards is crucial. Experience with regulatory submissions, risk management, and regulatory strategy is essential. A bachelor’s degree in a related field (e.g., life sciences, engineering) is required, and additional certifications in regulatory affairs (e.g., RAC) are preferred.

What skills are important for this role?

Key skills for this role include strong attention to detail, effective communication, and the ability to navigate complex regulatory frameworks. You should also have excellent organizational and problem-solving skills, the ability to work independently, and the ability to collaborate with cross-functional teams. A strong understanding of regulatory submission processes and post-market surveillance will be critical for success.

What challenges can I expect in this role?

The challenges in this role include managing complex regulatory requirements across multiple regions, ensuring compliance for innovative imaging devices, and maintaining a balance between regulatory oversight and product development timelines. You will need to stay current with ever-evolving regulations and work under pressure to meet deadlines while ensuring compliance with all regulatory guidelines.

What is the expected impact of the Imaging Device Regulatory Affairs Associate on the company’s growth?

The Imaging Device Regulatory Affairs Associate will play a crucial role in ensuring that the company’s imaging devices meet regulatory requirements, facilitating timely market access and enabling the company to expand its product offerings. Your work will directly impact the company’s ability to launch new products, maintain compliance, and strengthen its position in the competitive medical device market.

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

The company fosters a collaborative and dynamic work environment. You will work alongside passionate professionals committed to delivering innovative healthcare solutions. The culture values continuous learning, compliance, and teamwork, providing opportunities for personal and professional growth. You will be part of a company that prioritizes quality, safety, and regulatory excellence.
What Remuneration Can You Expect from This Job?
As the Imaging Device Regulatory Affairs Associate in Kansas City, MO, you can expect a competitive compensation package designed to reward your expertise and contributions to the company’s regulatory affairs operations. The remuneration for this role typically includes:

Base Salary

The base salary for an Imaging Device Regulatory Affairs Associate varies depending on experience and the company’s size, with the annual base salary typically ranging from $70,000 to $110,000. For more experienced candidates or those with specialized skills, salaries can be higher.

Performance-Based Bonuses

In addition to the base salary, many companies offer performance-based bonuses. These bonuses are tied to individual and company performance metrics, such as successful regulatory submissions, compliance maintenance, and timely product approvals. Bonuses can range from 5% to 20% of the base salary, depending on performance.

Equity & Stock Options

Some organizations may provide equity-based incentives such as stock options or performance shares, allowing employees to benefit from the company’s long-term success. These incentives help align individual contributions with company performance, offering financial rewards over time.

Health & Wellness Benefits

As part of the compensation package, you will receive comprehensive health benefits, including:

Health, dental, and vision insurance
Life insurance
Health savings accounts (HSA) or flexible spending accounts (FSA)
Wellness programs, such as gym memberships or mental health support


Retirement & Financial Benefits

The company may offer retirement benefits such as a 401(k) plan with company matching, pension plans, or other financial planning options to ensure long-term financial security.

Professional Development & Training

To foster continuous learning and growth, many companies offer professional development stipends or reimbursement for certifications, courses, and seminars relevant to the regulatory affairs field. This ensures you stay ahead in an ever-evolving industry.

Relocation Assistance (if applicable)

For candidates relocating to Kansas City, the company may offer relocation assistance to cover moving expenses, temporary housing, and other associated costs.
Total Compensation Potential
When considering base salary, bonuses, benefits, and potential equity incentives, the total compensation for an Imaging Device Regulatory Affairs Associate can range from $80,000 to $130,000 or more annually, depending on experience, performance, and company benefits.
How to Apply
If you are an experienced and strategic professional with a solid background in regulatory affairs and imaging devices, we invite you to apply for the Imaging Device Regulatory Affairs Associate role in Kansas City, MO. This is a fantastic opportunity to contribute to a growing company, ensuring compliance with regulatory standards, and assisting with the successful launch of cutting-edge imaging products.
To apply, please submit your updated resume along with a cover letter. In your cover letter, highlight your experience in regulatory affairs, specifically within the imaging device industry, your familiarity with FDA regulations, and your ability to handle complex regulatory processes. Additionally, demonstrate your ability to work collaboratively with cross-functional teams, drive successful product approvals, and maintain compliance throughout the product lifecycle.
This role offers a meaningful opportunity to impact the future of the company’s regulatory strategies and innovation in imaging devices. Apply today to take the next step in your regulatory affairs career!
For more information or to explore similar opportunities, visit our Regulatory Affairs Careers Page.
Tags: Regulatory Affairs Associate | Imaging Devices | FDA Compliance | Medical Device Regulations | Regulatory Submissions | Imaging Device Regulatory Affairs | Medical Device Industry Jobs | Regulatory Affairs Careers