Regulatory Affairs Engineer

Job Type: Location Type: Not Specified

 

Summary

The Regulatory Affairs Engineer is responsible for the regulatory compliance of all submissions and supporting interactions with notified bodies, regulatory authorities, and/or governmental agencies. This position supports organizational compliance with regulations and works closely with global project teams to ensure all domestic and international requirements are fulfilled. As part of the Regulatory Affairs team, this position will support a high level of client satisfaction related to regulatory interpretation and guidance, helping to guide effective decision making in the context of regulatory requirements.

In This Position, You Will Have the Opportunity To

Market Clearance:

• Supports the review of updated technical publications and standards to ensure continued compliance
• Prepares and maintains Regulatory submissions for US and OUS which may include 510(k), STED Files, Technical Documentation, and similar submissions for ROW (Rest of World)
• Reviews and approves document changes, change requests, change orders, and product changes to ensure regulatory compliance is maintained throughout their lifecycle
• Creates, maintains, and revises STED File/Technical documentation to ensure compliance with current regulatory standards and product information
• Supports international registration activities required by our customers or international distributors
• Supports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers
• Reviews and approves sales and marketing literature to ensure compliance is maintained
• May assist with execution of annual Regulatory activities (i.e. FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG)
• Assist with necessary registrations and licensing for new products and acquisitions
• May lead or participate in various regulatory projects as assigned
• Supplies regulatory agencies with requested information
• Supports regulatory audits
• Supports label change projects by providing feedback to assure regulatory requirements are met
• Performs labeling review and verification activities
• Manages or supports aspects of Post Market Surveillance including updates to Risk Management Files, Post Market Surveillance Reports, Clinical Evaluation Reports, etc.
• Provides assistance related to field safety concerns including HHEs, product notifications, and recall activities
• Other duties as assigned by Manager

What You Need to Succeed in This Position

• Bachelor’s Degree or combination of equivalent education and experience; M.S. in a technical area or M.B.A. is preferred
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) is a plus
• 1+ year work experience in a regulated industry (e.g., medical devices, combination products)
• 1+ years’ experience in regulatory affairs and/or product development in medical devices Medical device, biological, or pharmaceutical environment preferred
• Must have knowledge of ethical guidelines of the regulatory profession, clinical research, and regulatory process
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents; principles and requirements of applicable product laws
• Knowledge of International submission/registration types and requirements; domestic and international guidelines, policies, and regulations (GxPs (GCPs, GLPs, GMPs).
• Experience with principles and requirements of promotion, advertising, labeling, and EU Medical Device Regulation
• Technical writing experience strongly preferred
• Strong verbal, written and interpersonal communication skills
• Team player with ability to facilitate meetings with cross functional teams
• Effective research and analytical skills
• Ability to read, analyze and interpret legal documents, technical documents, professional journals, and financial reports
• Ability to manage problems involving several concrete variables in standardized situations
• Strong planning and organizational skills
• Excellent computer skills including but not limited to Microsoft Office

QUALITY AND REGULATORY REQUIREMENTS:

• Quality system knowledge including the quality manual, quality policy, and applicable procedures and work instructions
• Report status and any needed improvement of the quality system to the RA Manager
• Establish, implement, and maintain the quality system in accordance to FDA, ISO 13485, European Union Medical Device Regulations, Japanese Ministry of Health and Welfare, and Canadian Medical Device Regulations
• The Regulatory Affairs Engineer in conjunction with the RA Manager has the authority to define methods and mandatory procedures and to reject procedures and products that do not conform to company, regulatory or customer quality standards.
• Responsible for reviewing all regulatory affairs company document on Aspen’s behalf relating to Domestic and International requirements

PHYSICAL REQUIREMENTS:

NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function, and the applicant is unable to perform such function with or without reasonable accommodation

Please refer to Essential Duties and Responsibilities.

We’re proud to be an equal opportunity employer- and celebrate our employees’ differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.