Global Compliance Lead
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Job Title: Global Compliance Lead
Department: Global Quality
Reports To: Global Compliance Head
The Global Compliance Lead will oversee the compliance program at a functional level for all medical devices globally. Most importantly, this individual will serve as the "face" of Church & Dwight Co., Inc. to the Authorities and certifying bodies and will work objectively to provide strategic guidance on compliance issues or concerns within Church & Dwight.
The incumbent directs the medical device compliance & auditing program of the corporation, ensuring that all products are designed, manufactured, tested, stored and distributed in accordance with regulatory guidelines and company policies, standards and procedures and meet the requirements of the domestic and international regulatory authorities. This position also oversees and audits programs to assure compliance with all requirements, ensuring continued product distribution in key markets and aiming to avoid costly recalls or other regulatory sanctions.
Role Accountabilities and Responsibilities
- Oversees the C&D medical device auditing & inspection program, ensuring compliance with applicable regulations and standards in a consistent manner globally.
- Supports regulatory agency audits globally (FDA, HC and International Authorities) and certifying bodies (ISO, GMed) which includes inspection readiness, inspection conduct, and inspection responses for all medical devices globally. Ensures adherence to regulatory commitments and ensures continued certifications.
- Deploys medical device audit readiness and assures that all sites are inspection ready.
- Identifies potential areas of compliance vulnerability and risks.
- Monitors compliance engagement, or where appropriate, corrective action plans.
- Acts as the channel of communication for compliance related issues as per C&D Escalation Policy.
- Provides strategic guidance on compliance issues and situations.
- Manages day-to-day compliance related questions and issues.
- Leads medical device recalls, market withdrawals, and other regulatory actions, when required.
- Leads global regulatory standards management, responsible for communicating new health authority requirements and updates to standards across medical devices to the organization and supporting the Global Quality Management Systems Head in updating all appropriate policies and procedures. Special projects and other duties as assigned.
- Cross-functionally partners with R&D, Regulatory, Legal, Operations & Human Resources.
Education and Experience
- BS/MS degree in Science or Engineering from accredited institution in related field
- Minimum of combined ten years’ experience in medical devices, including quality assurance, regulatory compliance, and/or R&D
- Experience leading certification audits, both front room and back room, with demonstrated proficiency in successful audit outcomes
- Experience working in an inclusive environment and can effectively collaborate within a global organization
Skills and Competencies
- Excellent knowledge of regulations governing medical devices, specifically device regulations in U.S., Canada, UK, Europe, Australia, as well as standards ISO 13485:2016, ISO 14971, MDSAP, MDD, IVD, MDR, IVDR)
- Excellent leadership and influence skills, with both technical and non-technical partners
- Ability to handle ambiguity and complex situations
- Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude
- Ability to think strategically and to translate strategy into action plans
- Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player
- Ability to work with all levels of management and build relationships across disciplines
- Excellent communication and presentation skills
COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.
*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ
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/
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As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to email@example.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to firstname.lastname@example.org or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More