What you will do

As the Senior Regulatory Affairs Specialist you support new product development and sustaining for both US and OUS global regulatory release through the development and execution of regulatory strategies in accordance with applicable regulatory requirements. You support the total product lifecycle by assessing changes made to the device post-launch to determine the regulatory impact of changes. You will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies. You are viewed as the primary regulatory team resource.

• Evaluates engineering changes to existing products to determine regulatory impact. Creates and updates regulatory deliverables as needed

• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

• Evaluates proposed products for regulatory classification and jurisdiction

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance

• Assists other departments in the development of SOPs to ensure regulatory compliance

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

• Provides regulatory information and guidance for proposed product claims/labeling

• Review collateral material associated with new launches and ongoing product support.

What you need

Required

• Bachelor’s degree (B.S. or B.A.) required

• 2+ years of working in an FDA regulated industry

• 2+ years of medical device regulatory affairs experience

• Previous experience with Class I and II Medical Devices

Preferred

• Bachelor's degree in Engineering, Biological Sciences or equivalent focus

• RAC certification or Advanced Degree (Masters in Regulatory Affairs or Engineering)

• Previous experience with software Medical Devices

• Experience interacting with regulatory agencies

• Demonstrated success in management of global regulatory strategy and submission activities

• Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)

• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements