Global Regulatory Head - Medical Devices

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Role Summary                                                          

Reporting to the AVP – Global Regulatory Affairs, the Senior Manager of Global Regulatory Affairs for Medical Devices is the global Regulatory subject matter expert (SME) for medical devices. This position is responsible for the strategic direction, development and implementation of regulatory policies, processes and programs to enable global expansion of the Company’s medical devices sold by the Company’s international subsidiaries and through the Global Markets Group (GMG) to distributors worldwide. S/he will work closely within the GMG R&D Center of Excellence to ensure appropriate communication, escalation and prioritization of issues. This includes monitoring and communicating external developments, assessing the impact to the Company’s ability to sell and helping to develop compliance plans. This position works with outsourcing partners to create regulatory strategies to enable successful market entry. Deliverables may include but are not limited to regulatory classification, regulatory pathways, regulatory requirements, file gap assessment, labeling rules, conformity assessment procedures, mandatory standards, and other aspects related to global category expansion. This role manages the output, budget and relationship with Company’s consulting partners and Teams of Teams to enable agile delivery to internal Regulatory staff and to other business partners. As the internal SME, this position supports regulatory inspections and certification audits relevant to medical device conformity assessment and registration in the Company’s subsidiary markets.

Strategy and Functional Expertise

• Consulted internally, and sometimes externally, as an expert in at least one area
• Develops strategy; provides technical direction to others and ensures that execution delivers on targeted goals
• Keeps accurate documentation and submits detailed reports to appropriate executives
• High attention to detail, organization and accuracy
• Ability to think strategically and to creatively translate strategy into action
• Contributes to policy, strategy implementation, and execution of relevant policies and procedures
• Develops strategies that position the business to shape and to capitalize on emerging market needs and regulatory requirements

Leadership and Influence

• Is regarded as a corporate and industry resource in the field
• Well organized and demonstrates forward leaning and high initiative
• Ability to influence cross functionally to deliver against business goals and objectives
• Demonstrates strong leadership skills
• Leads and directs strategic programs focused on meeting regulatory requirements
• May manage and develop other members of the team
• Mentors others in technical areas of expertise
• Demonstrates broad business orientation
• Communicates the vision and strategy in a way everyone can relate to and motivates others to action
• Shows personal commitment to the vision and creates energy and optimism
• Keeps current on trends in the marketplace, with the competition, and in the organization

Program Development/Program Management

• Adept at presenting Regulatory information in a manner that allows the businesses to realize the impact and the implications to make an informed decision
• Monitors project progress and sets deadlines and budgets
• Solves issues quickly and efficiently
• Ensures stakeholder satisfaction
• Delivers project tasks on time
• Works cross-functionally to identify and communicate regulatory requirements
• Oversees implementation of new requirements to ensure adherence
• Monitors spend and identifies additional project needs
• With R&D Center of Excellence, evaluates project performance 
• Creates and leads Teams and Teams of Teams
• Prioritizes and handles multiple projects simultaneously
• Communicates and engages appropriately with regulators, notified bodies and trade associations, conducting sensitive conversations in a confidential manner
• Provides clear direction, removes obstacles, and holds self and others accountable
• Monitors progress by maintaining dialogue on work and results
• Makes good and timely decisions that keep the organization moving forward

Impact/Reach

• Strong execution skills, though contributions are generally more strategic than executional; independent
• Demonstrates agility and connectivity across the organization
• Actively builds connections and partnerships with others, internally and externally
• Ability to work with all levels of Marketing, PD, Quality, Supply Chain and Technology teams to build relationships across functions
• Strong communications and the ability to adjust content and delivery to meet the needs of the audience  
• Creates and captures value for Regulatory and the business
• Participates in due diligence assessment and integration of new acquisitions
• Actively participates in industry fora and external scientific/technical meetings as necessary to maintain regulatory knowledge and expertise

Education and Experience                                                           

• University degree from an accredited institution in a related field
• Professional typically with at least 12-15 years’ technical experience and a demonstrated track record
• High level and scope of decision-making authority

Skills and Competencies

• Ability to develop and implement complex global regulatory strategies
• Practical understanding, interpretation, and application of U.S. and international standards and regulations applicable to medical devices, including ISO 13485, MDSAP and the EU Medical Device Regulation
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
• Ability to think strategically and creatively and to translate strategy into action plans.
• Ability to prioritize and to handle multiple projects simultaneously.
• Ability to work with all levels of management and to build relationships across disciplines.
• Excellent influence, persuasion, communication, and presentation skills.

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Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/