Title : Regulatory Affairs Specialist Role
Location : Hybrid (remote + Onsite)
Duration: 12+ months Contract
The EU Regulatory Affairs Specialist is responsible for developing regulatory strategy and preparing EU submissions and obtaining approval to ensure the continued regulatory compliance of existing products and therapies on markets during the EU MDR transition.
This role focuses on regulatory support for the EU markets, as the RA Specialist reviews remediated documentation and pulls together EU MDR submissions for higher classification devices. In this role, you will have primary RA responsibility for multiple Class I, Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.
From developing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the worlds leading medical device company.
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for on-market products.
Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Provide support to currently marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval.
Review product changes
Manages submission activities for a variety of device regulatory approvals including the CE mark change notifications and new CE product certifications.
Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel
Ensure personal understanding of all quality policy/system items that are personally applicable
Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Other duties as assigned
Bachelor’s Degree (Engineering or Chemistry) plus 8+ years of regulatory experience in the medical device industry.
Master’s Degree in Regulatory Science with 5+ years of regulatory experience in the medical device industry
Job Types: Full-time, Contract
Pay: $30.00 – $80.00 per hour
8 hour shift
Ability to commute/relocate:
West Chester, PA: Reliably commute or planning to relocate before starting work (Preferred)
regulatory affairs medical device: 3 years (Required)
medical device: 5 years (Required)
Day Shift (Preferred)
Work Location: One location