Regulatory Affairs Manager
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.
In addition to the tasks listed, you may be required to undertake other duties, from time to time, as the business requires.
The Regulatory Affairs Manager provides Regulatory strategy and direction from product concept to launch through the product lifecycle, with emphasis on medical devices but also supporting other products as assigned. Provides subject matter expertise on medical devices; advises and guides the regional and global cross-functional teams on regulatory requirements for approval and maintenance of regulatory registrations. Provides technical mentorship to junior team members within and outside Global Regulatory Affairs. Serves as a lead technical interface for the department. Acts a key liaison between the Company and regulatory approval authorities (e.g., US FDA, Notified Bodies).
- Lead product development initiatives from conception, through development, evaluation, pre-launch, launch, and post-launch.
- Identify regulatory requirements and optional pathways to market.
- Manage, guide, help write, and submit US FDA medical device submissions, including 510(k)s, De Novos, etc. Negotiate directly with the Agency to obtain and to maintain product clearances/approvals.
- Define the data required for building the global dossier/technical file to enable efficient approach to new product development.
- Provide regulatory information, guidance and strategy for product development and planning throughout the product lifecycle. Evaluate regulatory impact of proposed changes to marketed products and communicate clear actions to maintain product registrations and certifications.
- Monitor and communicate regulatory intelligence to assist in the development of business and compliance plans.
- Provide regulatory information and guidance for proposed product claims and labeling. Approve product artwork and promotional materials.
- Lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation and implementation of new internal policies and procedures. Assist other departments to develop SOPs as needed to ensure regulatory compliance.
- Simplify regulatory information and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Review and approve all design control documentation, change requests for device design, manufacturing, and labeling changes to ensure compliance with health agency regulations.
- Represent Regulatory function in external and internal inspections (FDA, Notified Body, MDSAP).
- Ensure all assigned records to support inspections are established, maintained, documented, are closed in a timely manner and according to QMS procedures.
- Perform other duties as assigned.
- May have direct reports.
Qualifications, knowledge, training or experience required for the post.
- Bachelor’s or Master’s degree in a scientific discipline or equivalent is required.
- Experience in submission writing and review is required.
- Minimum 8 years regulatory experience, with at least 5 years’ technical experience in obtaining regulatory clearance/approvals for medical devices in the US and EU.
- Expertise in class 2 or class 3 medical devices is required; knowledge of electrical and electromechanical products and in vitro diagnostics is a plus.
- Knowledge of the Regional and Global regulatory environment for medical devices and how it impacts regulatory pathways, dossiers and registrations.
- Strong understanding of medical device quality system requirements (e.g., 21 CFR 820, ISO 13485, MDR/IVDR)
- Excellent influence, persuasion, verbal and written communication skills.
- Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Individuals must demonstrate the ability to collaborate successfully in a dynamic and culturally diverse workplace.
- Ability to consistently deliver quality work in a high-pressure environment.
- Excellence in solving complex problems, project strategy, execution, and collaboration skills.
- Comfort and skill to work in fast-paced environment, independently and without much assistance from management team.
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.
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