Dental Devices Regulatory Affairs Coordinator – Columbus, OH
Are you an expert in regulatory affairs within the medical device sector? We are seeking a highly skilled and motivated Dental Devices Regulatory Affairs Coordinator to join our team in Columbus, OH. This is an exciting opportunity for a professional who is passionate about ensuring compliance, driving regulatory strategies, and contributing to the success of cutting-edge dental technologies.
Shape the Future of Dental Device Regulation
Our company, a leading player in the dental devices industry, is looking for a Regulatory Affairs Coordinator to oversee the regulatory approval processes for innovative dental products. Based in Columbus, OH, this role will focus on navigating the complexities of regulatory requirements, managing submissions, and ensuring that all products meet the necessary standards for market entry. If you have a strong background in dental device regulations and are looking to contribute to a forward-thinking company, this position is your next career move.
Key Responsibilities of the Dental Devices Regulatory Affairs Coordinator – Columbus, OH
Regulatory Compliance & Submissions:
Manage the preparation and submission of regulatory documents for dental devices, ensuring compliance with all local, state, and federal regulations. Coordinate submission strategies and timelines to achieve timely market entry for new products.
Regulatory Strategy Development:
Collaborate with cross-functional teams, including product development, marketing, and manufacturing, to define regulatory strategies that align with business goals. Develop and execute strategies to navigate complex regulatory landscapes and ensure successful product approvals.
Product Registration & Approval:
Coordinate the regulatory approval process for new dental products, including the submission of 510(k) premarket notifications, PMA applications, and international regulatory filings. Ensure that all products meet the necessary regulatory standards and requirements.
Cross-Functional Collaboration:
Work closely with R&D, quality assurance, and manufacturing teams to provide regulatory guidance throughout the product development lifecycle. Facilitate communication to ensure all departments are aligned with regulatory requirements.
Risk Management & Compliance Monitoring:
Identify and assess potential regulatory risks and ensure the implementation of strategies to mitigate those risks. Monitor changes in relevant regulations and proactively update internal processes and product documentation to ensure ongoing compliance.
Documentation & Reporting:
Ensure that all regulatory filings, reports, and correspondence are accurate, complete, and properly documented. Maintain up-to-date records of product approvals and regulatory submissions for internal and external audits.
Regulatory Training & Support:
Provide training and regulatory support to internal teams, ensuring awareness of regulatory requirements and standards. Guide product teams on best practices to maintain compliance throughout the product lifecycle.
Market Surveillance & Post-Market Activities:
Monitor and assess the regulatory status of products in the market. Handle post-market surveillance activities, including managing adverse event reporting, field corrective actions, and ensuring ongoing compliance with regulatory bodies.
Stakeholder Communication:
Serve as the primary liaison between regulatory agencies and internal teams, effectively communicating regulatory requirements and feedback from authorities. Ensure that key stakeholders are informed of any regulatory changes or challenges.
What the Client is Looking for in You
As the Dental Devices Regulatory Affairs Coordinator, the client is seeking an experienced and highly motivated professional who can navigate the complexities of the dental device regulatory landscape. You should be a detail-oriented, strategic thinker with a deep understanding of regulatory requirements and a passion for ensuring compliance while supporting the development of innovative dental technologies.
Proven Expertise in Regulatory Affairs
The client is looking for a candidate with solid experience in regulatory affairs, specifically within the dental devices or medical device sectors. You should have a strong background in navigating FDA regulations, international guidelines, and the submission processes for medical devices, including 510(k) filings. A proven track record of managing successful product registrations and ensuring regulatory compliance throughout the product lifecycle is highly valued.
Strong Understanding of Regulatory Requirements
You will be expected to possess a deep understanding of regulatory requirements for dental devices, including FDA regulations, ISO standards, and other relevant international guidelines. The client values candidates who are proactive in staying current with evolving regulations and are capable of effectively interpreting and applying them to product development and market approval.
Excellent Cross-Functional Collaboration Skills
Collaboration is key in this role. The client seeks someone who can work effectively with teams across product development, quality assurance, marketing, and manufacturing. You should be able to provide regulatory guidance and support while ensuring that the regulatory aspects are integrated seamlessly into the development process. Strong communication and interpersonal skills are essential to foster alignment across departments.
Detail-Oriented with a Focus on Compliance
The client values individuals who have a keen eye for detail and a commitment to maintaining high standards of compliance. You should be capable of managing complex regulatory documentation, ensuring that all filings are accurate, complete, and submitted on time. A systematic approach to managing submissions, approvals, and risk assessments is essential in this role.
Problem-Solving and Risk Management Abilities
The ideal candidate will possess excellent problem-solving skills and the ability to navigate challenges in the regulatory process. You should be adept at identifying potential risks and developing strategies to mitigate them. A proactive approach to ensuring compliance and addressing regulatory issues will be highly valued.
Ability to Work Independently and Manage Multiple Priorities
The client seeks a self-starter who can manage multiple regulatory projects simultaneously. You should be able to work independently, prioritize tasks effectively, and meet deadlines in a fast-paced environment. The ability to manage competing priorities while maintaining a high level of accuracy and compliance is essential.
Strong Communication and Reporting Skills
Clear communication with both internal teams and regulatory bodies is key to success in this role. You should be able to write clear and concise regulatory documents, prepare reports, and communicate effectively with stakeholders at all levels. The ability to present complex regulatory information in an accessible and actionable way is critical.
Commitment to Continuous Learning and Development
Finally, the client values individuals who are committed to continuous professional development and who stay abreast of the latest regulatory changes and industry trends. A proactive approach to learning and a passion for advancing the dental device industry through innovation and compliance will make you a standout candidate for this role.
FAQs About the Role – Dental Devices Regulatory Affairs Coordinator – Columbus, OH
1. What are the key responsibilities of the Regulatory Affairs Coordinator in this role?
As the Dental Devices Regulatory Affairs Coordinator, you will be responsible for managing regulatory submissions for dental products, ensuring compliance with FDA and international regulations, and coordinating product registrations. You will also collaborate with cross-functional teams, assist with risk management, and monitor post-market activities. Additionally, you will maintain detailed documentation and report on regulatory compliance status to internal and external stakeholders.
2. What qualifications and experience are required for this position?
The ideal candidate should have a background in regulatory affairs within the medical or dental devices industry. A solid understanding of FDA regulations, ISO standards, and experience with 510(k) and other regulatory filings is essential. Previous experience in managing product registrations, conducting regulatory risk assessments, and working with cross-functional teams is highly valued. A degree in life sciences, engineering, or a related field is required, and certifications in regulatory affairs (e.g., RAC) are preferred.
3. What regulatory knowledge and skills are necessary for this role?
You will need a comprehensive understanding of dental device regulations, including FDA 21 CFR Part 820 (Quality System Regulations) and 21 CFR Part 807 (Medical Device Registration). Experience with international regulatory processes and certifications (e.g., CE marking) is also beneficial. Strong skills in preparing regulatory documents, interpreting guidelines, and understanding post-market surveillance requirements are essential for success in this role.
4. What challenges can I expect in this role?
In this role, you will face challenges related to staying up to date with evolving regulatory requirements, ensuring timely submissions, and managing multiple projects under tight deadlines. Additionally, you will navigate the complexities of international regulatory landscapes and work with cross-functional teams to ensure compliance throughout the product lifecycle. Managing risk and resolving compliance issues will also be critical to your success.
5. What is the expected impact of this role on the company’s success?
As the Regulatory Affairs Coordinator, your work will directly impact the company’s ability to bring new dental devices to market efficiently and compliantly. By ensuring smooth regulatory submissions and maintaining compliance, you will help the company reduce time to market, mitigate regulatory risks, and contribute to the overall success of the product portfolio.
6. What is the company’s culture and work environment like?
The company fosters a collaborative and supportive work environment with a strong focus on innovation and compliance. You will work closely with product development, quality assurance, and manufacturing teams in a fast-paced, dynamic setting. The company values attention to detail, continuous learning, and a proactive approach to solving regulatory challenges. The culture emphasizes teamwork, accountability, and a commitment to maintaining high regulatory standards.
What Remuneration Can You Expect from This Job?
As the Dental Devices Regulatory Affairs Coordinator in Columbus, OH, you can expect a competitive and attractive compensation package tailored to industry standards for regulatory affairs professionals. The remuneration for this role typically includes:
1. Base Salary
The base salary for a Dental Devices Regulatory Affairs Coordinator in the medical device industry varies depending on the level of experience and the company’s size. Generally, the annual base salary can range from $80,000 to $120,000. For candidates with more experience or specialized expertise, higher salaries may be offered.
2. Performance-Based Bonuses
In addition to the base salary, many regulatory affairs roles include performance-based bonuses. These bonuses are typically tied to key metrics such as successful regulatory submissions, product approvals, and compliance achievements. Bonuses can range from 5% to 20% of the base salary, depending on individual and company performance.
3. Equity & Stock Options
While less common in regulatory affairs roles, some companies in the dental or medical device sectors offer equity-based incentives, including stock options or restricted stock units (RSUs). These incentives align employee compensation with company performance and shareholder value, providing long-term financial rewards.
4. Benefits & Perks
Comprehensive benefits are typically included, such as:
- Health, dental, and vision insurance
- 401(k) or pension plans with company contributions
- Paid time off (PTO), sick leave, and holidays
- Professional development support and training opportunities
- Wellness programs and mental health support
5. Signing Bonuses & Relocation Assistance
For candidates with specialized skills or experience, some companies may offer signing bonuses or relocation assistance to facilitate your transition to Columbus, OH. Signing bonuses typically range from $5,000 to $20,000, and relocation packages may cover moving expenses, temporary housing, and travel costs.
Total Compensation Potential
When factoring in base salary, bonuses, benefits, and other perks, total compensation for a Dental Devices Regulatory Affairs Coordinator typically ranges from $90,000 to $140,000 annually. In larger companies or roles with additional responsibilities, the total compensation could exceed this range.
How to Apply
If you are an experienced and strategic professional in regulatory affairs with a proven track record in the medical device industry, we invite you to apply for the Dental Devices Regulatory Affairs Coordinator role in Columbus, OH. This is an exciting opportunity to play a crucial role in the regulatory processes of a dynamic dental devices company and ensure the successful approval and compliance of innovative dental products.
To apply, please submit your resume along with a cover letter that highlights your experience in regulatory affairs within the dental or medical device industry. In your cover letter, be sure to demonstrate your expertise in navigating regulatory requirements, your experience with FDA submissions, and your understanding of compliance practices in the dental device field. We also encourage you to provide examples of how you have contributed to successful product approvals and regulatory strategy development.
This role offers a great opportunity for personal and professional growth, where you will have a direct impact on the regulatory success and market presence of dental devices. If you’re ready to take the next step in your regulatory affairs career, apply today!
For more information or to explore similar opportunities, visit our Dental Devices Careers Page.
Tags:
Dental Devices Regulatory Affairs | Regulatory Affairs Jobs | Medical Device Compliance | FDA Submissions | Dental Device Industry | Regulatory Strategy | Compliance Management | Dental Device Approvals
