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Jed Graham
Regulatory Process Manager
Summary
Highly accomplished and results-oriented Regulatory Process Manager with over 10 years of experience in the medical device industry. Possesses a deep understanding of FDA, EMA, and ISO regulatory guidelines and has successfully implemented comprehensive regulatory compliance frameworks. Proven ability to develop and execute regulatory strategies that minimize risk and maximize compliance for new product launches. Experience in conducting thorough risk assessments, developing mitigation plans, and managing regulatory submissions. Strong communication and relationship-building skills with regulatory agencies. Expertise in quality management systems (ISO 13485 and 21 CFR Part 820).
Education
Master’s in Regulatory Affairs
August 2019
Skills
- Regulatory Affairs Management
- Quality Management Systems (QMS)
- Regulatory Compliance
- Medical Device Regulatory Affairs
- Drug Regulatory Affairs
- Medical Device Quality Assurance
Work Experience
Regulatory Process Manager
- Established and maintained strong relationships with regulatory agencies, facilitating effective communication and timely resolution of issues.
- Managed and tracked regulatory submissions, ensuring timely and accurate delivery of documentation.
- Provided expert guidance and support to internal stakeholders on regulatory requirements and best practices.
- Developed and implemented quality systems to ensure compliance with regulatory standards, including ISO 13485 and 21 CFR Part 820.
Regulatory Process Manager
- Established and implemented a comprehensive regulatory compliance framework, ensuring adherence to FDA, EMA, and ISO guidelines.
- Developed and executed regulatory strategies that minimized risk and maximized compliance for new product launches.
- Collaborated with crossfunctional teams to streamline regulatory processes, reducing submission timelines by 25%.
- Conducted thorough risk assessments and developed mitigation plans to address potential regulatory concerns.
Accomplishments
- Streamlined regulatory approval processes by 20%, reducing product launch time to market.
- Developed and implemented a comprehensive regulatory monitoring system, ensuring realtime compliance updates.
- Reduced regulatory violations by 35% through proactive risk assessment and mitigation strategies.
- Successfully negotiated regulatory exemptions, enabling business expansion into new markets.
- Established a team of regulatory experts, enhancing compliance efficiency and knowledge sharing.
Awards
- Received Excellence in Regulatory Compliance award for outstanding contributions to regulatory adherence.
- Recognized as Regulatory Compliance Champion for exceptional expertise in regulatory affairs.
- Honored with Innovator in Regulatory Compliance award for pioneering new approaches to regulatory management.
- Recipient of Regulatory Excellence Award for contributions to regulatory best practices.
Certificates
- Regulatory Affairs Certified Professional (RACP)
- Certified Medical Device Regulatory Affairs Specialist (CMDRAS)
- Certified Quality Auditor (CQA)
- Certified Clinical Research Professional (CCRP)
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How To Write Resume For Regulatory Process Manager
- Highlight your experience in managing regulatory compliance for medical devices, pharmaceuticals, or other healthcare products.
- Quantify your accomplishments with specific metrics, such as the percentage reduction in submission timelines or the number of successful product launches.
- Showcase your knowledge of regulatory guidelines and industry best practices, including FDA, EMA, and ISO.
- Emphasize your ability to collaborate with cross-functional teams and build strong relationships with regulatory agencies.
- Consider obtaining certifications, such as the Regulatory Affairs Certification (RAC) or the Certified Quality Auditor (CQA), to demonstrate your expertise.
Essential Experience Highlights for a Strong Regulatory Process Manager Resume
- Establish and implement comprehensive regulatory compliance frameworks to ensure adherence to FDA, EMA, and ISO guidelines.
- Develop and execute regulatory strategies that minimize risk and maximize compliance for new product launches.
- Collaborate with cross-functional teams to streamline regulatory processes, reducing submission timelines.
- Conduct thorough risk assessments and develop mitigation plans to address potential regulatory concerns.
- Manage and track regulatory submissions, ensuring timely and accurate delivery of documentation.
- Provide expert guidance and support to internal stakeholders on regulatory requirements and best practices.
- Develop and implement quality systems to ensure compliance with regulatory standards, including ISO 13485 and 21 CFR Part 820.
Frequently Asked Questions (FAQ’s) For Regulatory Process Manager
What is the role of a Regulatory Process Manager?
The role of a Regulatory Process Manager is to ensure that a company complies with all applicable regulations. This involves developing and implementing regulatory compliance frameworks, conducting risk assessments, and managing regulatory submissions.
What are the key skills and qualifications for a Regulatory Process Manager?
Key skills and qualifications for a Regulatory Process Manager include a deep understanding of regulatory guidelines, experience in managing regulatory compliance, and strong communication and relationship-building skills.
What are the career prospects for a Regulatory Process Manager?
Regulatory Process Managers can advance to senior-level positions within the regulatory affairs function, such as Regulatory Affairs Director or Vice President of Regulatory Affairs.
What is the average salary for a Regulatory Process Manager?
The average salary for a Regulatory Process Manager varies depending on experience and location, but it is typically around $100,000 per year.
What are the typical working hours for a Regulatory Process Manager?
Regulatory Process Managers typically work regular business hours, but may need to work overtime during peak periods or to meet deadlines.
What are the top companies that hire Regulatory Process Managers?
Top companies that hire Regulatory Process Managers include Johnson & Johnson, Medtronic, and Pfizer.
What is the job outlook for Regulatory Process Managers?
The job outlook for Regulatory Process Managers is expected to be positive in the coming years due to increasing regulatory requirements in the healthcare industry.