Regulatory Affairs Specialist 3 - medical device/510k experience

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve. Job Title: Regulatory Affairs Specialist 3

• Would prefer candidates that have had hands on experience with products and are coming from medical device.
• Exp with 510ks.
• There is no sponsorship for this position and candidates can be remote anywhere but have to be able to support EST.

Location: REMOTE Duration: PERM Shift: M-F 1st Shift Notes:

• Supporting Breast & Skeletal division
• This can be fully remote and requires travel to various sites but primarily the Newark, DE location as needed.

Job Summary: 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. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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.

Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls. Travel (please specify): Occasional, Apply tot his job Apply To this Job