Regulatory Specialist – Neuro Devices – Cleveland, OH
Are you an experienced regulatory professional with a passion for the neuro devices sector? We are looking for a Regulatory Specialist to join our team in Cleveland, OH, focusing on the innovative and fast-growing field of neurotechnology. This is an exciting opportunity to contribute to the development and approval of cutting-edge neuro devices while ensuring compliance with regulatory standards. If you have a deep understanding of regulatory processes and a drive to make a difference in the healthcare industry, this is the role for you.
Drive Regulatory Excellence in Neuro Devices
A leading company in the neuro devices industry based in Cleveland, OH, is seeking a Regulatory Specialist to lead the regulatory affairs efforts for their innovative product line. The ideal candidate will have expertise in medical device regulations, including FDA submissions, and a strong understanding of neurotechnology. In this role, you will ensure that all products meet the necessary regulatory requirements, enabling the company to bring life-changing solutions to market efficiently. If you have a background in neuro devices and thrive in a collaborative environment, join us in shaping the future of healthcare technology.
Key Responsibilities of the Regulatory Specialist – Neuro Devices
Regulatory Strategy & Compliance: Develop and implement regulatory strategies to ensure compliance with FDA, EU, and other global regulatory bodies for neuro devices. Manage and prepare submissions for regulatory approvals, including 510(k), PMA, CE Mark, and other applicable certifications.
Product Development Support: Collaborate with cross-functional teams, including R&D and product development, to ensure regulatory requirements are met throughout the product lifecycle. Provide guidance on design controls, risk management, and clinical evaluations.
Regulatory Submissions & Documentation: Prepare, review, and submit regulatory documentation, including technical files, labeling, and marketing authorization applications. Ensure all submissions are accurate, complete, and timely to meet regulatory timelines.
Risk Management & Quality Assurance: Support the development and implementation of risk management strategies to comply with international standards, including ISO 14971. Assist with quality assurance and maintain a robust post-market surveillance program to identify any compliance issues.
Regulatory Intelligence: Stay up-to-date with the latest regulatory trends, guidelines, and legislation in the neuro devices sector. Provide insights and recommendations to leadership based on changes in regulatory requirements or industry standards.
Cross-Functional Collaboration: Work closely with product development, manufacturing, clinical, and quality assurance teams to ensure regulatory requirements are integrated into all stages of product development and commercialization.
Audit & Inspection Support: Prepare and support regulatory audits and inspections by regulatory bodies. Address any findings, ensuring timely resolution and compliance with industry standards.
Post-Market Surveillance: Ensure ongoing compliance through effective post-market monitoring. Collect and evaluate product performance data, addressing any regulatory issues that arise post-launch.
Training & Guidance: Provide regulatory training and guidance to internal teams to foster a culture of compliance and ensure understanding of regulatory requirements in product development and commercialization processes.
Regulatory Strategy Development: Help define regulatory pathways for new products and provide regulatory insights to help shape product strategy and development timelines.
What the Client is Looking for in You
As a Regulatory Specialist – Neuro Devices, the client is seeking a highly skilled and detail-oriented regulatory professional with deep knowledge of the medical device industry, specifically neurotechnology. The ideal candidate should have a strong ability to navigate complex regulatory processes, ensure compliance with global standards, and support the development of innovative neuro devices.
Proven Expertise in Regulatory Affairs for Medical Devices
The client is looking for a candidate with a strong background in regulatory affairs, especially within the medical device or neurotechnology sector. You should have experience preparing and submitting regulatory filings such as 510(k), PMA, and CE Mark applications. A proven track record of managing the entire regulatory process, from initial development through post-market surveillance, is essential.
In-Depth Knowledge of Global Regulatory Standards
The client values expertise in FDA, EU MDR, and other global regulatory frameworks governing medical devices. You should be familiar with the requirements and standards for neuro devices, including quality management systems (QMS) and risk management, to ensure compliance and support efficient product development and approval processes.
Strategic Thinking and Problem Solving
As a Regulatory Specialist, you will need to think critically and strategically, especially when navigating regulatory pathways for complex neuro devices. The client is looking for someone who can anticipate regulatory challenges, propose solutions, and contribute to the creation of innovative products while ensuring compliance with relevant standards and guidelines.
Strong Attention to Detail and Organizational Skills
The client seeks a candidate who excels in managing the intricate details of regulatory documentation and submissions. The ability to maintain accuracy, meet deadlines, and handle multiple regulatory projects simultaneously is crucial for success in this role.
Collaborative and Cross-Functional Team Player
This role requires a collaborative approach, as you will be working closely with R&D, product development, quality assurance, and clinical teams. The ideal candidate will have strong interpersonal skills and the ability to communicate regulatory requirements effectively to diverse teams, ensuring seamless project execution from development to market.
Proactive and Results-Oriented
The client values candidates who take a proactive approach to regulatory challenges and are results-driven. You should have the ability to stay ahead of regulatory changes, actively seek out best practices, and ensure that the company’s neuro devices are compliant with all necessary regulations for successful market entry.
Commitment to Continuous Learning and Industry Knowledge
Given the rapidly evolving landscape of the neuro devices industry, the client seeks a candidate who is committed to staying up-to-date with regulatory trends, technological advancements, and industry standards. Ongoing professional development and a passion for the field will be highly valued.
FAQs About the Role – Regulatory Specialist – Neuro Devices
1. What are the key responsibilities of the Regulatory Specialist in this role?
As the Regulatory Specialist, you will be responsible for developing and executing regulatory strategies for neuro devices, ensuring compliance with FDA, EU, and other global regulatory standards. You will handle submissions for regulatory approvals, maintain technical documentation, manage post-market surveillance, and collaborate with cross-functional teams to ensure compliance throughout the product lifecycle. Additionally, you will stay up-to-date with regulatory trends and contribute insights to product development and strategy.
2. What qualifications and experience are required for this position?
The ideal candidate should have a strong background in regulatory affairs within the medical device or neurotechnology sectors. You should have experience managing regulatory submissions such as 510(k), PMA, CE Mark, and other relevant certifications. Knowledge of FDA regulations, ISO standards, and risk management is essential. A degree in a related field (e.g., biomedical engineering, life sciences) and certifications in regulatory affairs (e.g., RAC) are preferred.
3. What specific skills are needed for this role?
The client seeks candidates with strong knowledge of regulatory processes, excellent attention to detail, and the ability to navigate complex regulatory environments. Strong communication skills are vital for collaborating with internal teams and external regulators. You should also be adept at managing multiple projects simultaneously, ensuring timely regulatory submissions and compliance. A proactive approach to staying informed about changing regulations and industry standards is crucial.
4. What challenges can I expect in this role?
You can expect to face challenges such as staying updated with rapidly evolving regulations, managing multiple regulatory submissions for different products, and coordinating across teams with varying expertise. Additionally, navigating the complexities of neuro device regulations and ensuring timely approvals in a competitive market can present challenges. You will also need to address any post-market compliance issues that may arise.
5. What impact will the Regulatory Specialist have on the company’s growth?
The Regulatory Specialist plays a critical role in ensuring that the company’s neuro devices meet the necessary regulatory standards, enabling the products to reach the market efficiently and safely. Your expertise in regulatory affairs directly impacts the company’s ability to launch innovative products, maintain compliance, and sustain growth in the neurotechnology sector. Successful regulatory management can open the door to market expansion and improved product offerings.
6. What is the company’s culture and work environment like?
The company fosters a collaborative and innovative work environment where cross-functional teamwork is highly valued. The culture emphasizes continuous learning, professional development, and adaptability in a dynamic industry. You will work closely with talented professionals across various departments, contributing to the development of cutting-edge neuro devices while maintaining a focus on regulatory compliance and industry standards.
What Remuneration Can You Expect from This Job?
As the Regulatory Specialist – Neuro Devices in Cleveland, OH, you can expect a competitive compensation package that reflects the expertise and experience required for this critical role in the neurotechnology industry. The remuneration typically includes:
1. Base Salary
The base salary for a Regulatory Specialist in the neuro device industry varies depending on your experience, qualifications, and the size of the company. In a mid-to-large-sized company, the annual base salary can range from $80,000 to $120,000, with higher salaries possible for candidates with more extensive experience or expertise in neuro device regulations.
2. Performance-Based Bonuses
In addition to a base salary, performance-based bonuses may be included in the compensation package. These bonuses are typically linked to key performance indicators such as successful regulatory submissions, approval rates, and on-time product launches. Bonuses can range from 10% to 20% of the base salary, depending on company performance and individual contributions.
3. Equity & Stock Options
Some companies in the neuro device industry offer equity-based compensation, such as stock options or restricted stock units (RSUs). These incentives provide long-term financial rewards and align your compensation with the success and growth of the company. The equity component is typically a smaller portion of the overall package but can grow significantly over time.
4. Benefits & Perks
The company will provide a comprehensive benefits package that may include:
- Health, dental, and vision insurance
- Retirement plans (401(k) or pension)
- Paid time off (PTO) and sick leave
- Life and disability insurance
- Wellness programs
- Professional development opportunities
- Flexible work schedules or remote work options, depending on the company’s policies
5. Signing Bonuses & Relocation Assistance
For highly qualified candidates, the company may offer signing bonuses or relocation assistance, especially if you are moving from a different region. Signing bonuses typically range from $5,000 to $20,000, depending on experience, while relocation assistance can cover moving costs and other associated expenses.
Total Compensation Potential
When factoring in base salary, bonuses, benefits, and any equity incentives, the total compensation for a Regulatory Specialist – Neuro Devices can range from $90,000 to $150,000 annually. Higher compensation packages are possible for candidates with significant experience in regulatory affairs or specialized knowledge in neuro devices.
How to Apply
If you are a dedicated and experienced regulatory professional with a strong background in neuro devices, we encourage you to apply for the Regulatory Specialist – Neuro Devices role in Cleveland, OH. This is a fantastic opportunity to contribute your expertise in regulatory affairs and help shape the future of neurotechnology.
To apply, please submit your updated resume and a cover letter detailing your experience in regulatory compliance for medical devices, specifically within the neuro devices sector. In your cover letter, highlight your familiarity with FDA regulations, EU MDR, and other relevant regulatory requirements. Emphasize your ability to manage regulatory submissions, lead audits, and collaborate with cross-functional teams to ensure successful product approvals and market entry.
This role offers a significant opportunity to impact the neuro device industry, ensuring regulatory excellence and contributing to the development of cutting-edge medical technologies.
For more information or to explore similar opportunities, visit our Medical Device Regulatory Careers Page.
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