Regulatory Affairs Manager

About Aspen

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.


Summary

The Regulatory Affairs Manager is responsible for the regulatory strategy of all submissions and managing interactions with notified bodies, regulatory authorities, and/or governmental agencies. This position drives 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 drive 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:

• Determine requirements and generate market clearance applications, as needed, for US and OUS which may include 510(k), STED Files, Design Dossiers and similar submissions for ROW (Rest of World). Support Global Expansion & in-country RA personnel for ROW global product registrations. Create and maintain product summary technical documentation (STED) to support global product registrations
• Support international registration activities required by our customers or international distributors
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing
• Ensure annual Regulatory activities are completed (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses)
• May serve as primary interface with the notified body including relationship management, audit scheduling, and related follow-up activities
• Manage ISO and CE certifications to ensure all required internationally sold devices are accurately depicted
• Review labeling, IFU's, advertising, promotional items, sales and marketing literature to ensure all comply with related standards
• Provide Regulatory support for New Product Development which includes product classification review and regulatory submission requirements
• Responsible for supporting research, development, and sustaining engineering teams on required medical device performance and safety standards. Review scientific/engineering materials (protocols/reports), support continuous improvement activities and provide regulatory assessment on proposed changes to marketed devices
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of QA/RA and related teams
• Participate in Risk Management and Post Market Surveillance as part of a cross-functional team
• Monitor and submit applicable vigilance reports and ensures appropriate responses are submitted to regulatory authorities
• Responsible for keeping the product portfolio in compliance with worldwide standards and regulations by maintaining awareness of changing global regulatory requirements / technical publications and communicating the impact to internal teams to implement the required updates. Facilitates communication and tracking of changes to regulations and standards by creating, maintaining and updating a library of information.
• Support regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers
• Review and approve customer and distribution QA/RA contracts to ensure conformance and accuracy of content
• Provide assistance in product notification and recall activities
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
• Manage product change control to ensure regulatory compliance is maintained throughout changes

What You Need to Succeed in This Position

• Bachelor's Degree or equivalent job 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
• 5+ year work experience in a regulated industry (e.g., medical devices, combination products)
• 5+ years' experience in regulatory affairs and/or product development in medical devices Medical device, biological, or pharmaceutical environment preferred Note: Higher education may compensate for years of experience
• 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 VP of QA/RA
• Establish, implement, and maintain the quality system in accordance to FDA, ISO 13485, European Union Medical Device Directives, Japanese Ministry of Health and Welfare, and Canadian Medical Device Regulations
• The Regulatory Affairs Manager in conjunction with the Director of QA/RA 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 and signing all regulatory affairs company document on Aspen's behalf relating to Domestic and International requirements
• Serves as US Agent on behalf of Aspen
• Define, document, and review the quality system and policy
• Ensure the quality policy is understood, implemented, and maintained at all levels of the organization
• Ensure the quality system is effectively established and maintained per FDA, ISO 13485, European Union Medical Device Directives, Canadian Medical Device Regulations, and Japanese Ministry of Health & Wellness

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.