Regulatory Affairs Specialist

OrthoPediatrics•Warsaw, IN

3h•Onsite

About The Position

The Regulatory Affairs Specialist will act as a regulatory representative on cross-functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work closely with each project team to develop regulatory strategies, testing requirements, and other documentation to ensure that regulatory submissions are prepared and cleared/approved to meet the company's product launch timelines for new and modified products.

Requirements

Demonstrate a fundamental understanding of medical device terminology, anatomy, regulations, standards and technical concepts
Understanding of regulations and guidelines governing all phases of Medical Device development with guidance and supervision.
Understanding new product development requirements and processes with guidance and supervision.
Excellent technical writing and editing skills, verbal and written communication skills including presentation skills.
Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities.
Able to work within deadlines as imposed by government regulations and internal guidelines.
Able to take direction and work and solve problems both independently and as part of a team.
Ability to read and comprehend instructions, correspondence, and memos.
Ability to prepare routine reports and correspondence.
Ability to communicate effectively with customers, vendors and other employees of the organization.
Requires excellent grammar and spelling.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
Requires a valid driver’s license.
Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc.
Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

Nice To Haves

Advanced degree preferred.
Minimum of 2 years’ experience in regulatory of medical devices is preferred.

Responsibilities

Work closely with each New Product Development team in developing the regulatory strategy for the new and modified products.
Work closely with the product managers to understand the country’s registration needs and priorities and provide regulatory input to the product managers such as registration strategies, timeline, and costs.
Work closely with engineering team on the testing requirements and support the development of verification and validation testing plan. Review engineering documentation under the design history file to ensure compliance with the standards, guidance, and regulatory requirements.
Prepare regulatory submissions such as 510(k), Letter to File, Health Canada Submission, Technical Files, etc. for new and modified devices.
Updates and maintains databases with required information and status for UDI, GUDID, licenses, approvals, renewals, and other required data to assure compliance with business and regulatory requirements.
Review and approve product, supplier, and manufacturing changes for compliance with applicable regulations and applicable procedures. Work closely with Regulatory and Clinical Affairs team members to provide regulatory change assessments for each country/region where the products are registered.
Work closely with Regulatory and Clinical Affairs team members in monitoring the impact of changing regulations of each country on submission requirements and strategies.
Assign, review, revise and approve device labeling and marketing materials to ensure continued compliance with global regulations.
Provide support in developing regulatory procedures when necessary.
Provide regulatory input for product recalls and recall communications.
Performs other duties as assigned.