Regulatory Affair & Quality Manager in Nationwide India at KaVo Kerr

Date Posted: 6/6/2019

Job Snapshot

Job Description

Job ID: KAV003946

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description

Purpose of Position:

Ensure full compliance with any applicable regulatory and quality requirements of all regulatory bodies related to the import, export, supply and distribution of the products in KaVo Kerr, Ormco and Dental Platform portfolio, for countries in scope. Portfolio includes but not limited to: digital imaging systems and associated treatment planning software, dental equipment and instruments, dental orthodontic products, dental restorative and endodontic products, dental implant systems.
Act as Regulatory Business Partner to the Commercial Team and provide regulatory strategies and executable regulatory plans that support fast market access and commercial revenue and growth targets. Work closely with RA teams within local distributors, headquarter KaVo Kerr, Ormco and Dental Platform for strategy development and execution.
Be knowledgeable and keep track of the local regulatory requirements. Work closely with RA teams within local distributors, headquarter KaVo Kerr, Ormco and Dental Platform to bring local country requirements into global processes.
Act as a link between the company and regulatory authorities, ensuring that products are imported and distributed in compliance with appropriate legislation.

Key Responsibilities

Product Registration/Licensing Management 
• Provide innovative regulatory strategies for new products and any changes in targeted markets to drive competitive advantage. 
• Identify gaps that may impact implementation and translate local/ global regulatory strategies into executable local plans. 
• Manage product registration planning including change notification and renewal, develop registration dossiers from regional dossier template for submission, and monitor the progress, status and timelines. 
• Communicate and work closely with all relevant stakeholders such as Regional/ Global RA team, Authorities, business partners and regulatory consultants abroad to deliver regulatory outcomes to enable business plans. 
• Manage the regulatory approval for new registration and variations of medical devices in assigned geographies by ensuring quality and timely submission to regulatory bodies to add value to faster GTM and business growth. 
• Obtain timely renewal of product licenses and maintain registration database. 
• Manage applicable licenses/ certificates to ensure medical devices comply with any other applicable regulatory requirements of other regulatory bodies (e.g. AERB-Atomic Energy Regulatory Board, BIS-Bureau of Indian Standards, etc.) 
• Keep abreast of the regulatory changes and trends in assigned geographies and provide assessments of the impact of new and changing regulations on company’s areas of interests to the management. Keep business informed in a timely manner on emerging regulatory issues and develop strategies to mitigate regulatory risks. 

Job Requirements



Qualifications

RA/QA Matters Handling 

• Manage post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions including product recalls and collaborate
with Global QA team and business partners to ensure timely report to the Authorities till the closure. 
• Implement and maintain the Quality Management System for dental platform entities in accordance with specific country’s requirements to possess the valid Establishment and to ensure business continuity. 
• Develop and implement the required standard operating procedures, and execution of trainings on regulatory and quality topics within India and South India region.
• Work with business strategic direction and perform with independent judgment which directly impacts the operational results of the local markets. 
• Manage RA/QA partners screening and periodic review process using dental platform Channel Partner Toolkit (CPTK) and ensure our RA/QA partners in India and South India region to act with the same level of integrity required of us under Danaher’s Standards. Build Continuous Awareness within Organization on applicable RA Framework 
• Represent strongly India and South India Affiliate Regulatory Affairs interest and be an outstanding business partner with Regional Sales and Marketing teams. 
• Establish and build on relationships with key contacts within the organization to support the countries, so as to strengthen relationship with the industry association, regulatory agencies and with external stakeholders. 
• Lobby and influence the formulation of regulations, anticipate and shape the external environment to create or leverage opportunities. • Participate in ad-hoc projects.
Internal Relationship
• Direct reports to Senior regional RAQA Manager.
• Work closely with regional & global RA teams, Marketing, Commercial & Customer Service teams.
• Interacts with Finance, Service Engineers.
External Relationship
• Channel Partners
• Regulatory authorities
• Other relevant government agencies
Measurement
• Project delivered on time / report out
• Implementation of RAQA processes for continuous improvements
• Level of Danaher Business System (DBS) zealotry and implementation
Requirement for the Position
• Education: A minimum of a bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.
• Experience: At least more than 5 years’ experience in Regulatory Affairs. Thorough understanding of regulatory requirements for medical device products industry. Experience in preparation, submission of regulatory submissions for countries in scope.
Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
• Language Skills: Fluent English - oral and written. Proficiency in MS Office, Excel and Adobe Acrobat.
• Travel: 10-20%
Most Important Competencies Required
• Good understanding and application of knowledge of regulatory guidelines and requirements of the countries.
• Effective planning, organization, and leadership skills.
• Able to engage effectively with regional/global corporate headquarters to get the support and resources necessary to successfully execute the RA strategy and plan.
• Strong analytical & outstanding problem-solving skills.
• Excellent project management skills and ability to manage multiple priorities concurrently.
• Hands-on, detail-oriented and meticulous.
• Excellent communication (written and verbal) and relationship development skills.
• Ability & experience interfacing at all levels of the organization.
• Strategic vision while balancing successful execution
• Ability & willingness to lead and work in a matrix organization with direct & indirect reporting relationships.
• Self-motivated, self-organized, and able to work with minimum supervision.
Personal Skills / Attributes
• Independent personal traits – integrity, charisma, sound judgment, decision-making capability.
• Mental agility. Bright, flexible, thoughtful, creative. Ability to grasp and analyze situations quickly and at the same time to create and implement innovative ideas to build strategies for implementation in a structured way.
• Maturity, positive approach to problem solving, good business instincts, well developed sense of personal accountability.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.