Regulatory Affairs Manager

Regulatory Affairs Manager AXIOMED SPINEFRONTIER
Join our crew! KICVentures is a private investment company founded in 2005 by Harvard-trained Dr. Kingsley R. Chin, who brings unique experience to the intersection of medicine, business and information technology. We’re equipped to identify niche healthcare opportunities and encourage total global inclusion, beginning with our team. We’re about hands-on, heads-down efforts, complemented by a company culture that fosters engagement. Collaboration drives our innovation, and we work with the best and the brightest in the business – movers and shakers who’re all hands on deck for success. As evolution happens, we revolutionize.
Position Overview
This is a joint position shared between AxioMed and sister company SpineFrontier but with majority of work on AxioMed to start.
The Regulatory Affairs Manager will work as a member of the Quality and Regulatory group to ensure timely and successful regulatory submissions for US FDA, European MDD/ MDR, and MDSAP. This position will participate heavily with the Quality team to assure compliance, effectiveness, and maintenance of the quality management system and promote knowledge of regulatory requirements throughout the company. It will support reporting activities both within US and EU vigilance reporting. This position will serve as the RA representative on product development teams, facilitate compliance efforts across the organization. This position will be responsible for setup, management, and overall compliance of GUDID systems.
This is an opportunity for an experienced Regulatory Affairs Manager to apply their knowledge and clearly see the benefits realized from their individual contribution. This role also provides an opportunity for professional growth.
General Responsibilities
• Manage EU MDD technical file, clinical evaluation reports, essential requirements
• Planning and writing regulatory submissions/documents, including but not limited to:
Premarket notifications (510(k))
Premarket Applications (PMA) – original or supplements
Investigational Device Exemptions (IDE)
Design Dossiers
Renewals
Technical Files
Change Notifications
Letters to File
• Providing regulatory assessments and input to product development teams
• Defining efficient regulatory pathways and rationale
• Communicating and negotiating with FDA personnel
• Participating in risk management efforts with product development teams
• Assessing and determining regulatory impact of proposed design changes
• Documenting and appropriately communicating changes for cleared devices
• Manage GUDID requirements and GTIN database
Specific Responsibilities
• Manage EU MDD technical file, clinical evaluation reports, essential requirements
• Planning and writing regulatory submissions/documents, including but not limited to
Premarket notifications (510(k)
Premarket Applications (PMA) – original or supplement
Investigational Device Exemptions (IDE) Design Dossiers
Renewals
Technical Files
Change Notifications
Letters to File
• Providing regulatory assessments and input to product development teams
• Defining efficient regulatory pathways and rationale
• Communicating and negotiating with FDA personnel
• Participating in risk management efforts with product development teams
• Assessing and determining regulatory impact of proposed design changes
• Documenting and appropriately communicating changes for cleared devices
• Manage GUDID requirements and GTIN database
Required Competencies
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.
Position Requirements
The successful candidate will be required to possess:
• 7-10 years in a regulatory role in a medical device company, Spine preferred
• B.S. in engineering or sciences or MS Regulatory
• Experience writing successful regulatory submissions, especially 510(k),
• Strong knowledge of the QSR, ISO 13485, EU MDD, GUDID, and MDSAP
• Successful history serving as RA representative on product development teams
• Ability to work in a fast paced and dynamic environment
• Legally authorized to work in the United States on a regular full-time basis without restrictions
• RAC Certification and European language capability desired, both a plus
Physical Requirements
• This position operates in a mainly clerical setting. Routinely uses standard computer equipment, telephones, photocopiers, filing cabinets etc.
• Sitting for extended periods of time using a computer keyboard and monitor
• Frequently communicates with employees and vendors who have inquiries. Must be able to read, write and communicate to exchange accurate information in these situations.
• Must be able to read, write and communicate fluently in English.
• Required to have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
• Required to have close visual acuity to perform and analyzing data and figures, viewing a computer terminal; extensive reading at a distance that is close to the eyes.
• Travel up to 10% and may include international travel
Environmental Factors (optional)
Work is generally performed within an office environment, with standard office equipment available.