Regulatory Reporting Manager
DePuy Synthes Companies of Johnson & Johnson, is the largest, most comprehensive orthopaedic and neurological business in the world, built upon the strong legacies of two great companies. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials.
Our broad array of inspired, innovative and high-quality offerings advance the health and wellbeing of people around the world.
DePuy Synthes established its manufacturing facility in Cork in 1997 where it manufactures orthopaedic knees and hips, from this date the company has expanded to include a Global Supply Chain Operation in 2002 and more recently in 2008 DePuy established an Innovation Centre which was created to develop next generation orthopaedic products and processes for a global market. In 2014, DePuy Synthes in Cork won the Shingo prize for Operational Excellence.
As a Regulatory Reporting Manager, your typical day may include:
- Manage day-to-day Quality Health Authority Reporting departmental activities, establishing department goals, managing workload, tracking classification accuracy and ensuring performance to plan.
- Work independently to manage and support MDR Associates
- Ensure development and adequate training of staff
- Develop Medical Surveillance/Vigilance staff, including development/succession planning, goals, performance feedback and support as required.
- Maintain and continuously improve the Vigilance and Reporting quality system to support business, meeting global vigilance standards and regulations.
- Monitor complaint classification processes to ensure timely and accurate submission of MDR/Vigilance reports to Health Authorities and timely responses to Health Authority inquiries.
- Serve as key point of contact for Health Authority inquiries. Leads follow-up investigations and coordinates/composes responses to Health Authorities.
- Act as primary point of contact for internal and external audits, from a Quality Health Authority Reporting perspective.
- Ensure continuous improvement of medical surveillance/ vigilance processes
- Complete investigations and timely corrective/preventive actions utilizing the non-conformance, CAPA and internal audit processes.
- Keep management abreast of department/reporting system issues and key metrics.
- Have an in-depth understanding and capable of supporting all advanced functions and specialty areas within Quality Health Authority Reporting organization.
- Represent the Quality Health Authority Reporting department to ensure flawless and timely IT system enhancements.
- Act as a key interface with internal and external customers
- Maintain continued awareness of emerging reporting requirements (worldwide)
- Monitor emerging worldwide reporting requirements and proactively prepare to meet new regulations.
To be part of this high performing team you will have:
- A minimum of a Bachelor’s Degree is required.
- Regulatory/Quality Systems experience
- 10+ years Medical Devices Industries experience
- 3+ years People Management Experience
- Broad experience and knowledge of world-wide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements
- Leadership and project management skills are required
- Demonstrated proficiency conducting investigations and implementing corrective and preventive actions
- Ability to work in a cross-functional and matrix environment.
- Actively participates in cross-functional team meetings.
- Requires organizational and critical thinking skills.
- Ability to prioritize and multi task.
- Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.
- Problem solving
- Strong verbal and written communication skills
- Knowledge of basic medical terminology.
- Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint).
- Ability to interface with technical and non-technical personnel at all organization levels.
- Excellent communication skills – both verbal and written
- Continuous Improvement Focus
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
- Committed to caring
- Responsible to our communities
- Ready to apply our knowledge and know-how
- Rare in our background and experiences
- The drivers of our own success
- Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com.