What are the responsibilities and job description for the Regulatory Affairs Specialist position at Actalent?
The Regulatory Affairs Specialist will be joining a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
Responsibilities
• Partner with Geography RA to plan, develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in International markets (such as Canada, LATAM, EMEA).
• Provide support to the Geography RA who interact with regulatory authorities to assure timely new product introductions and continued product access.
• Prepare submissions, interact more effectively with the regulatory agencies and negotiate submission issues as needed.
• Assist in keeping company informed of regulatory requirements in International markets
• Provide regulatory review of labeling, design changes, and specification changes as it relates to specific geographies
• Supports Geography RA team to prepare International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
• Supports International product demand planning and release activities
• Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures
• Supports post market regulatory compliance activities for International product approvals
• Develops and maintains regulatory affairs department procedures and process improvements
• Provide mentorship, training and support to other members of the department.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or 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.
• Other duties as assigned or required
Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelors degree and 2 years of regulatory experience or relevant medical device experience
OR
Advanced Degree with 0 years of regulatory experience or relevant medical device experience
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $40 - $43