Regulatory Affairs Manager

Aspen Surgical•Caledonia, MI

About The Position

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 devicesAnticipate 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

Requirements

Bachelor’s Degree or equivalent job experience
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
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
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 system knowledge including the quality manual, quality policy, and applicable procedures and work instructions

Nice To Haves

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
Medical device, biological, or pharmaceutical environment preferred
Higher education may compensate for years of experience
Technical writing experience strongly preferred

Responsibilities

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
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
Review and sign all regulatory affairs company documents on Aspen’s behalf relating to Domestic and International requirements
Serve 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