Vice President, Regulatory Affairs
4 weeks ago
Location: Onsite in West Lafayette, IN
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:
- Accountable: We own our actions and decisions.
- Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
- Growth Mindset: We embrace challenges as opportunities for continuous learning.
- Customer-Centric: We prioritize customers at every touch point.
- Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Job Title: Vice President of Regulatory Affairs
Department: Regulatory Affairs
Location: West Lafayette, IN
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
Responsibilities:
· Develops and executes global regulatory strategies for new product development, including pre-market submissions, regulatory clearance, and approvals
· Leads regulatory affairs team members, providing guidance, mentorship, and strategic direction
· Establishes and maintains relationships with regulatory authorities, industry organizations, and key stakeholders
· Interprets and communicates regulatory requirements and changes to cross-functional teams, ensuring compliance throughout the product lifecycle
· Collaborates with R&D, Quality Assurance, Clinical Affairs, and other departments to integrate regulatory considerations into product development activities
· Oversees regulatory submissions, including 510(k), PMA, IDE, CE Marking, and other global submissions
· Monitors and assesses regulatory developments and trends that impact medical device regulations globally
· Ensures compliance with quality system regulations (QSR), ISO standards, and other applicable requirements
· Represents the company during regulatory inspections and audits, providing support and guidance to ensure successful outcomes
· Other duties as assigned
Qualifications:
· Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred
· 10+ years in medical device regulatory affairs, with a proven track record of successful regulatory approvals
· Strong leadership skills with experience managing and developing high-performing teams
· Expert knowledge of FDA regulations (21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 807) and international medical device regulations (ISO 13485, MDD/MDR, etc.)
· Experience in regulatory strategy development and implementation across multiple geographic regions
· Excellent written and verbal communication skills, with the ability to effectively interact with internal teams, regulatory agencies, and external partners
· Strategic thinker with the ability to anticipate regulatory challenges and provide innovative solutions
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