US - Regulatory Affairs Specialist-Sr

The Fountain Group; Cordova (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

A national staffing firm is currently seeking a Regulatory Affairs Specialist in Cordova, TN. The successful candidate will manage regulatory submissions and develop strategies for product compliance in various markets. Responsibilities include preparing global submissions, ensuring regulatory compliance, and providing guidance to regulatory teams. This position offers competitive pay ranging from $36 to $39.29 per hour and lasts for one year.

Qualifications

• Experience in preparing global regulatory submissions including US 510(k) and EU submissions.
• Ability to develop and execute regulatory strategies for product launches.
• Familiarity with medical device regulations and compliance.

Responsibilities

• Prepare and review global regulatory submissions.
• Develop regulatory strategies for project teams.
• Maintain knowledge of global regulations and standards.
• Lead engagements with regulatory authorities.

Skills

Regulatory submission preparation

Regulatory strategy development

Knowledge of global regulations

Project management

Technical guidance

Education

Bachelor's degree in a relevant field

Job description

My name is Shivaraj, and I am a Talent Acquisition Consultant with The Fountain Group. We are a national staffing firm with an array of Fortune 500 clients and are currently seeking a Regulatory Affairs Specialist in Cordova, TN.

Details for the position are as follows:

Regulatory Affairs Specialist

Pay: $36 - $39.29 Per hour

Duration: 1 year

Job Description:

• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets.
• Manage/lead regulatory-driven project, as directed by management.
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
• Plan, lead and support for internal and Regulatory agency audits
• Lead and direct engagement with regulatory authorities as required
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
• Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Review product labeling to ensure compliance with regulatory requirements