Senior Regulatory Affairs Specialist

Overview

Position Summary:

Responsible to lead domestic and/or international registration and renewal activities for Werfen-labeled products.  Related duties include participation on design teams, authoring of regulatory assessments for both new products and product modifications, documentation of regulatory impact from device modifications, establishment and maintenance of Technical Files, labeling I advertising review and other regulatory work required to maintain domestic and international compliance.

Responsibilities

Key Accountabilities

Essential Functions:

Responsible to participate on design teams (both Hemostasis and Acute Care Diagnostics) as the Regulatory representative and provide guidance on domestic and international requirements, including:

• Author Regulatory Assessments I Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input. 
• Author Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.
• Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses, CFDA registration materials, Japan Shonin information).
• Prepare support materials for Milan Regulatory for other country registrations (e.g. Australia, Korea, Latin America).
• Prepare product renewal packages to maintain country registrations. 
• Responsible for the updating of Technical Files to ensure compliance. 
• Responsible for maintenance of Regulatory Database in SAP. 
• Responsible to review and approve Marketing promotional materials as determined by workload. 
• Responsible to review and approve labeling and Change Orders as determined by workload. 
• Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated. 
• Other assignments related to RA/QA to support Werfen requirements and priorities 

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Proficiency with standard software (Word, Excel, PowerPoint, etc.).
• Experience with SAP is a plus.
• Requires superior communication skills (verbal and written)

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Requires a Bachelor degree, preferably in Life Sciences
• Minimum of 5 years of experience in the Medical Device Industry or other highly regulated environment with experience in domestic and/or international product registrations (e.g. FDA 51 Ok, Canadian licenses, CE mark, CFDA registration)

International Mobility: Required:

• No

Travel Requirements: 

• Must be available to travel domestically and internationally as needed
• <10% per year