Regulatory Affairs Specialist 3

Hologic

5d•$92,000 - $144,000

About The Position

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. The position has primary responsibility for compliance with US, EU and Canadian regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for medical devices and includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing US promotional materials, and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through the collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments. Or: Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Supports product release process. The position has primary responsibility for compliance with international registrations to support worldwide product commercialization or continued market access for medical devices. Works to ensure that regulatory requirements continue to be met and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Requirements

Preferred Minimum Non-Technical Degree: College Degree
Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree
Preferred Minimum Non-Technical Degree: 5-8 Years
Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD
Experience with the creation of technical files and documentation
Experience working in regulated medical device industry.
Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
Proficient with technology applications such as MS Office,
Knowledge of ISO 13485, ISO 9001, FDA, and foreign regulatory requirements
Strong data and statistical analysis skills and ability to use data to make informed recommendations.
High degree of attention to detail

Nice To Haves

Regulatory Affairs Certification (RAC) is beneficial.
Project Management Experience is beneficial.

Responsibilities

Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections.
Participates in technical review of data or reports that will be incorporated.
Manage and maintain regulatory databases and technical files.
Participate in internal and external audits and investigations.
Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
Provides high-level regulatory support on projects and cross functional teams. Provides technical guidance on design reviews and regulatory strategies for product approval.
Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.
Maintains current knowledge of existing and emerging regulations, standards and laws.
Must follow all applicable FDA regulations and ISO requirements.