Regulatory Affairs Project Manager
Regulatory Affairs Project Manager Overview
The Regulatory Affairs Project Manager (RAPM) works with Regulatory and project team members to develop and execute regulatory plans for a global marketplace. S/he leads regulatory intelligence efforts for team members, helps ensures regulatory compliance of products and processes globally through management of department and interdepartmental process updates, and collects information to be provided in submissions. The RAPM provides Regulatory support for marketed products, (reviewing labeling, promotional materials, training materials, changes to existing devices and documentation). S/he trains and mentors regulatory team members and key personnel in emerging issues and changes in related procedures.
- Develops and executes regulatory plans for a global marketplace, including evaluation of effects of regulatory, design, and manufacturing changes on plans and plan revision where appropriate.
- Attends meetings and/or follows trade organizations and publications to stay aware of emerging issues.
- Manages collection and distribution of regulatory intelligence through trade organization event attendance, review of available publications, interaction with regulatory bodies or distributors, and/or use of regulatory intelligence providers.
- Reports relevant standards changes, helps determine impact and takes appropriate action.
- Assists in the development and maintenance of department procedures to ensure consistent, efficient and compliant regulatory processes.
- Assists in the determination of appropriate testing requirements for registration or renewal of registration for Acumed product.
- Ensures regulatory compliance of products and processes through management of or participation in department or interdepartmental process updates.
- Facilitates short and long term planning by creating and maintaining Regulatory timelines and ensuring they are functional, consistent and integrated to reflect cross-functional dependencies.
- Provides project team leadership as necessary.
- Determines appropriate documentation required for various submissions (aligned with strategy) and coordinates with functional team members to obtain this information.
- Conducts documentation reviews and change assessments, and determines required regulatory action (e.g. submissions, notifications).
- Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and reviews and approves labelling and advertisement/promotional material to ensure regulatory compliance.
- Leads or serves as regulatory representative in assigned projects or meetings to provide regulatory guidance to assure compliance with global regulatory requirements.
- Trains and mentors key personnel on new or existing regulatory policies and processes as well as emerging issues identified above.
- Bachelors of Science in science and/or engineering field. Advanced degree preferred.
- 5+ years of experience in medical device industry
- 5+ years of experience in regulatory affairs
- Demonstrated experience preparing submissions (e.g. 510(k), technical file) and interacting with FDA, EU notified body and/or other regulatory agencies.
- Experience with 21 CFR part 820, ISO 13485, EU Medical Device Directive, and other applicable medical device regulations and standards (e.g. ISO 14971).
- Experience with project management
- Working knowledge of Acumed product
- Demonstrates strong analytical, problem solving, and technical writing skills
- Ability to work well with others, manage multiple projects simultaneously, and mentor/train others
- Proven track record of strong team work and creative strategic thinking
- Excellent written and verbal communication skills
- Ability to read and speak English sufficiently to read, understand and complete all documentation
- Regulatory Affairs Certification (RAC) preferred
Meet Some of Acumed's Employees
Regulatory Specialist 2
Janki prepares, reviews, and submits technical documentation to various health authorities—ensuring that Acumed receives the necessary registration for its products in all of the countries where it operates.
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