Are you an experienced risk management professional with a strong background in the medical device industry? We are seeking a Director of Risk Management (Med Device) in Newark, NJ, to oversee risk assessment, compliance strategies, and regulatory adherence. This executive role requires a proactive leader who can implement effective risk mitigation strategies, ensure FDA and ISO compliance, and drive continuous improvement in risk management practices.
As the Director of Risk Management (Med Device) in Newark, NJ, you will play a critical role in safeguarding the organization against potential risks, ensuring product safety, and maintaining regulatory compliance. If you have expertise in risk assessment methodologies, regulatory compliance, and quality systems in the medical device sector, this is an outstanding opportunity to make a significant impact.
About This Role
The Director of Risk Management (Med Device) in Newark, NJ will lead all aspects of risk identification, mitigation, and regulatory compliance within the organization. This role requires a detail-oriented professional who can develop and implement risk management frameworks, collaborate with cross-functional teams, and ensure adherence to industry regulations such as FDA, ISO 14971, and MDR.
As a key leader in the company, the Director of Risk Management (Med Device) in Newark, NJ will work closely with product development, quality assurance, and regulatory affairs teams to identify potential risks and develop strategies to mitigate them. This position offers an exciting opportunity to contribute to patient safety, product integrity, and overall corporate risk management in a rapidly evolving medical device landscape.
Key Responsibilities – Director of Risk Management (Med Device) in Newark, NJ
Develop and Implement Risk Management Strategies
- Establish and maintain a robust risk management framework that aligns with industry best practices.
- Identify, assess, and prioritize risks across product lines and business operations.
- Implement proactive strategies to minimize risk exposure and enhance regulatory compliance.
Ensure Compliance with FDA, ISO 14971, and MDR Regulations
- Oversee adherence to regulatory requirements, including FDA, ISO 14971 (Risk Management for Medical Devices), and MDR.
- Conduct internal audits and risk assessments to ensure compliance with evolving regulatory standards.
- Collaborate with regulatory affairs teams to address compliance issues and implement corrective actions.
Conduct Risk Assessments and Hazard Analyses
- Lead risk analysis processes for medical devices, including Failure Mode and Effects Analysis (FMEA).
- Evaluate potential hazards, assess their impact, and recommend mitigation strategies.
- Document risk assessments and ensure proper integration into product development and post-market surveillance.
Oversee Product Safety and Quality Risk Management
- Ensure that risk management principles are integrated into product design, development, and lifecycle management.
- Work with engineering and quality teams to identify safety concerns and implement risk control measures.
- Monitor product performance and implement post-market risk mitigation strategies as needed.
Lead Cross-Functional Risk Management Initiatives
- Collaborate with R&D, manufacturing, and quality assurance teams to embed risk management into company processes.
- Conduct training programs to enhance risk awareness and compliance across departments.
- Provide risk management insights to executive leadership for strategic decision-making.
Manage Incident and Crisis Response
- Develop protocols for managing product recalls, adverse event reporting, and regulatory investigations.
- Coordinate response efforts in case of product failures, legal claims, or safety concerns.
- Implement lessons learned from incidents to strengthen future risk management processes.
Monitor Emerging Risks and Industry Trends
- Stay up to date with changes in medical device regulations, emerging risks, and industry best practices.
- Adapt risk management policies to align with evolving regulatory requirements and technological advancements.
- Participate in industry forums, regulatory discussions, and risk management conferences.
Support Corporate Governance and Strategic Risk Planning
- Provide risk assessments and reports to senior management and board members.
- Develop corporate risk mitigation strategies aligned with business objectives.
- Ensure that risk management efforts support the company’s overall mission and long-term success.
What The Client is Looking For in You
To thrive as the Director of Risk Management (Med Device) in Newark, NJ, you should be a proactive and detail-oriented risk management professional with a strong background in regulatory compliance, risk assessment, and quality assurance within the medical device industry. The ideal candidate will bring:
- Extensive Experience in Medical Device Risk Management – A minimum of 10+ years of experience in risk management, regulatory compliance, and quality systems specific to the medical device sector.
- Regulatory Expertise – Deep knowledge of ISO 14971 (Risk Management for Medical Devices), FDA regulations, MDR (Medical Device Regulation), and ISO 13485 (Quality Management Systems for Medical Devices).
- Strong Analytical and Risk Assessment Skills – Experience conducting Failure Mode and Effects Analysis (FMEA), hazard identification, and root cause analysis to proactively mitigate risks.
- Leadership and Cross-Functional Collaboration – A track record of leading risk management initiatives, working closely with R&D, quality assurance, and regulatory affairs teams to drive compliance and safety.
- Crisis Management and Incident Response – Ability to oversee adverse event reporting, product recalls, and risk mitigation strategies in compliance with global regulations.
- Strategic Thinking and Continuous Improvement – A results-driven approach to enhancing risk management frameworks, ensuring operational excellence, and aligning risk strategies with business goals.
- Strong Communication and Stakeholder Management – Ability to effectively communicate risk insights to senior leadership, regulatory bodies, and cross-functional teams while fostering a culture of risk awareness and compliance.
If you have a passion for patient safety, regulatory excellence, and strategic risk management in the medical device industry, this is the perfect role for you!
Why This Opportunity Stands Out
As the Director of Risk Management (Med Device) in Newark, NJ, you will be stepping into a high-impact leadership role within a growing and innovative medical device company. This opportunity stands out because:
- Be a Key Player in Regulatory Excellence – Lead risk management strategies that directly impact patient safety, product integrity, and regulatory compliance.
- Work in a High-Growth Environment – Join a company that is expanding its medical device portfolio, offering exciting challenges and career growth opportunities.
- Competitive Compensation & Benefits – Enjoy an attractive salary package, performance-based incentives, comprehensive healthcare benefits, and executive-level perks.
- Lead Risk Strategy at an Executive Level – Collaborate directly with senior leadership, influencing the company’s risk governance and regulatory strategy.
- Impact the Future of Medical Device Innovation – Work on cutting-edge medical technologies, ensuring compliance while fostering product innovation.
- Global Industry Influence – Be at the forefront of medical device risk management, contributing to international compliance strategies and global market expansion.
If you are looking for an opportunity where you can lead, innovate, and shape the future of risk management in the medical device industry, this role offers the ideal platform for your expertise.
FAQs About the Role
Q: What industries should I have experience in?
A: Candidates should have extensive experience in the medical device industry, particularly in risk management, regulatory compliance, and quality assurance. Experience with FDA, ISO 14971, and MDR is essential.
Q: What qualifications are required for this role?
A: A bachelor’s or master’s degree in risk management, regulatory affairs, biomedical engineering, quality assurance, or a related field is required. Additional certifications such as RIMS-CRMP (Risk Management Professional) or RAC (Regulatory Affairs Certification) are a plus.
Q: What kind of leadership experience is necessary?
A: The ideal candidate will have at least 5+ years in a leadership role, overseeing cross-functional risk management initiatives, regulatory compliance strategies, and quality assurance programs.
Q: Will this role require travel?
A: Yes, this role may involve occasional domestic and international travel for regulatory meetings, audits, industry conferences, and risk assessment activities.
Q: What is the reporting structure for this position?
A: The Director of Risk Management (Med Device) in Newark, NJ will report directly to the Vice President of Quality & Regulatory Affairs and will collaborate closely with R&D, legal, and executive teams.
Q: What are the biggest challenges in this role?
A: Staying ahead of rapidly evolving regulatory requirements, managing risk across multiple product lines, and ensuring compliance in an ever-changing global market will be key challenges. Strong problem-solving and strategic thinking will be crucial.
Q: How does this role contribute to the company’s success?
A: The Director of Risk Management plays a vital role in ensuring product safety, regulatory compliance, and business continuity, directly impacting brand reputation, market approval, and financial performance.
Q: What is the hiring timeline for this role?
A: The company is actively looking to fill this position within the next 60–90 days. The hiring process includes initial screenings, leadership interviews, and final assessments before onboarding.
What Remuneration Can You Expect from This Job?
As the Director of Risk Management (Med Device) in Newark, NJ, you can expect a highly competitive compensation package that reflects the seniority and critical importance of this role. The base salary for this position typically ranges between $160,000 and $210,000 per year, depending on experience, expertise, and industry background.
In addition to the base salary, this role offers a performance-based bonus structure, with potential earnings increasing based on key performance indicators (KPIs) such as regulatory compliance success, risk mitigation effectiveness, and strategic contributions to corporate governance.
Beyond salary and bonuses, the total remuneration package includes:
- Comprehensive Health Benefits – Medical, dental, and vision coverage for employees and eligible dependents.
- Retirement & Stock Options – 401(k) with company match and potential stock equity options.
- Executive-Level Perks – Company-paid professional development, certifications, and industry conference participation.
- Flexible Work Arrangements – Hybrid work flexibility and paid time off (PTO), including vacation, personal, and sick leave.
- Long-Term Incentives – Career advancement opportunities and financial incentives for long-term contributions to the company’s success.
This is an exceptional opportunity to earn a lucrative compensation package while making a significant impact in the medical device industry.
How to Apply for This Director of Risk Management (Med Device) Position in Newark, NJ
If you are an experienced Director of Risk Management (Med Device) in Newark, NJ with a strong background in regulatory compliance, risk assessment, and quality management within the medical device industry, we encourage you to apply. This is an excellent opportunity to lead strategic risk management initiatives, ensure regulatory adherence, and drive patient safety within a dynamic and growing medical device organization.
To apply, please submit your resume and a cover letter detailing your experience in risk mitigation strategies, ISO 14971 compliance, and regulatory affairs within the medical device sector.
This role offers a rewarding opportunity to contribute to the safety, compliance, and success of a leading medical device company while working alongside top industry professionals. Apply today to take the next step in your career as a Director of Risk Management (Med Device) in Newark, NJ!
For more information or to explore similar opportunities, visit our Medical Device Recruiters page.
Tags:
Director of Risk Management | Medical Device Risk Assessment | Regulatory Compliance | FDA & ISO 14971 | Quality Assurance Leadership
