Regulatory Affairs Specialist I

Why Join Altus Spine

Altus Spine, located in West Chester, PA., is a global medical device technology company focused on providing the highest quality design and manufacturing of spinal implants and instrumentation. Altus offers an extensive portfolio of surgical systems to facilitate minimally invasive surgery (MIS), complex spine correction, and degenerative procedures. Continuous development and dedication to delivering inventive solutions and quality by design drives Altus’ commitment to the medical community. We invite you to become a member of an organization that has established an outstanding reputation for quality and excellence. Highly competitive wages, a state-of-the-art-facility, an emphasis on work/life balance, career advancement, a team-centered workplace culture, and the opportunity to be your best is waiting for you at Altus Spine.

Our company promotes an environment that allows for continuous growth and promotion opportunities!

What We Offer

• 100% Employer Paid Medical Plan
• Dental / Vision Benefits
• Work-Life Services Benefit Program (Employee Family)
• Group Life Insurance
• 401k retirement plans with employer match
• Personal Time Off (PTO)
• Holiday Pay
• Relocation Assistance
• Professional Development
• 100% Paid Uniforms

What You Will Do

• Implement all regulatory activities according to in-house procedures and regulatory requirements.

• Facilitate daily regulatory affairs activities under the guidance of the RA/QA manager.

• Support cGMP, good documentation practices, and Part 11 compliance.

• Maintain QA procedures for internal and vendor compliance with ISO 13485 and the FDA and international regulatory requirements, quality regulations and guidelines.

• Communicate with regulatory agencies; provide support to ensure that the company is 100% compliant with US and international regulatory requirements.

• Support Regulatory Affairs and Quality Assurance during FDA inspections, Notified Body audits and internal audits; participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits.

• Update US and international registration licensing and collect information on registration instructions/regs.

• Represent regulatory in project planning and design control meetings.

• Maintain current status of FDA submissions, ISO13485 and design deliverables for regular management update; coordinate efforts associated with the preparation of regulatory documents or submissions.

• Provide regulatory guidance to design team for device packaging labels, Instructions for Use, promotional material, sales training material; Review, edit, and approve device packaging labels, Instructions for Use, promotional material, sales training material in change control system.

• Audit FDA premarket submissions (including FDA 510k) prior to final ESTAR packaging.

Who You Are 

• Bachelor’s Degree in a scientific or engineering field or equivalent combination of experience. Minimum of 5 years working in the medical device industry within regulatory affairs role is required.
• FDA inspection and ISO audit lead experience desired. 

Skills and Competencies 

• Must have valid Driver’s License.
• Proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications.
• Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs).
• Must have proven successful CE marking of devices through design dossier or technical file process.
• Experience in medical devices, risk-based-analysis, root-cause analysis, and external standards (i.e. ISO) desired.
• Ability to use calipers, micrometers, and mechanical inspection instrumentation. RAM and Overlay experience a plus.
• Proficient with MS Office and experience with CAD software (Creo preferred)
• Direct experience with, or willing to train and/or obtain certificates to, ISO 13485, ISO 14971, cGMP, and other quality and regulatory systems that support medical device compliance and safety.
• Familiarity with the FDA UDI Rule and/or GS1 system and data standards is beneficial.

Altus Spine is proud to be an Equal Opportunity Employer. Altus Spine does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

*Principals only. Recruiters please do not apply on behalf of your candidate(s) to Altus Spine job posts. All applications and/or contact information submitted are kept on file and are the property of Altus Spine. Please note recruiting fees will not be honored when candidate application(s) are submitted by recruiter(s) or any other entity other than the actual candidate.

Join a team committed to improving lives!