New · posted Oct 15
Artivion · Medical Devices
Senior Director, Regulatory Affairs - Product Development
- Kennesaw, GA
- On-site
- Full-time
- Director
Open until filled
The role
The Senior Director Regulatory Affairs, Product Development will be responsible for setting enterprise-level global regulatory strategy for Artivion's new product development portfolio and leading the regulatory approach for complex, high-risk medical device programs from early feasibility through approval, launch and lifecycle expansion.
This role will lead senior Regulatory Affairs management and staff, serve as a senior regulatory decision-maker for assigned programs and represent Artivion with global regulatory authorities, notified bodies and other external stakeholders. The position is accountable for anticipating regulatory risk, resolving complex submission and agency issues, and ensuring clear, timely and compliant regulatory execution across regions.
What you need
Two ways to qualify
Bachelor’s
+ 12 years of experience
Minimum 12 years of experience in regulatory affairs or the medical device industry with bachelor's degree, including significant leadership experience, OR
- or
Master’s
+ 10 years of experience
Minimum 10 years of experience in regulatory affairs or the medical device industry with engineering degree and master's degree, including significant leadership experience.
- Bachelor's degree required in science, engineering, life sciences or related discipline; advanced degree in a relevant focus area preferred.
- Extensive experience defining and executing global regulatory strategies for Class II/III and high-risk medical devices across new product development and lifecycle management.
- Proven success leading or substantially influencing successful submissions and approvals, including IDE, PMA, HDE, PMA supplements, EU MDR technical documentation/CE Marking and international registrations such as ANVISA, PMDA, and Health Canada.
- Knowledge of and expertise in global medical device regulations, particularly US FDA, EU MDR, Canada, Latin America and Asia Pacific requirements.
- Experience leading direct interactions and negotiations with FDA, notified bodies and global regulatory authorities, including pre-submissions, deficiency responses, advisory panel preparation and inspection support.
- Demonstrated ability to align regulatory strategy with clinical evidence generation, pivotal studies, benefit-risk assessments, labeling, claims and commercialization plans.
- Experience with global quality system regulations and standards, including US FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, design controls and related medical device standards.
- Strong executive communication, influencing, negotiation and stakeholder management skills in complex, matrixed environments.
- Advanced analytical thinking skills; ability to understand principles of engineering, physiology, device design, medical device use and software/digital components, as applicable.
- Proven program and portfolio management skills with ability to assess, prioritize and complete multiple complex projects, tasks and responsibilities.
- Advanced personnel development, succession planning, budget/resource management and organizational design skills.
- High ethical standards, sound judgment and ability to lead through ambiguity while maintaining compliance, quality and patient safety focus.
What you'll do
- Establish, approve and oversee global regulatory strategies for emerging technology, product development, product registrations, lifecycle management and market access with domestic and international regulatory agencies.
- Lead portfolio-level regulatory planning for complex high-risk devices, including regulatory pathway, claims, labeling, evidence, timelines, resource plans and approval risk.
- Serve as the senior Regulatory Affairs representative to executive leadership, program governance and cross-functional product development teams; advise on regulatory risk, tradeoffs and go/no-go decisions.
- Influence and manage emerging and acquired technology opportunities and support integrations, as needed.
- Oversee and ensure timely, high-quality submissions to global regulatory agencies, including US FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses and international strategies for registration.
- Lead, prepare for and negotiate regulatory authority interactions, including FDA meetings, notified body reviews, competent authority engagement, advisory panel preparation, formal correspondence and complex deficiency resolution.
- Advise on clinical evidence strategies to support global approvals, including IDE/pivotal study design alignment, endpoints, follow-up expectations, post-approval commitments, real-world evidence and benefit-risk framing.
- Interpret current and evolving global medical device regulations, standards and guidance; assess enterprise impact and drive implementation plans that support compliant innovation and market access. Support global compliance programs.
- Partner with R&D, Clinical, Quality, Operations, Supply Chain, Marketing, Commercial and Legal to integrate regulatory requirements into design controls, manufacturing changes, labeling, promotional claims, launch readiness and pre- & post-market commitments.
- Direct regulatory assessments for new technologies, design changes, labeling and claims, product discontinuations, development partnerships and business development opportunities, as applicable.
- Contribute to commercial plans and advise on strategies to achieve regional and corporate objectives.
- Build, manage, mentor and succession-plan a high-performing Regulatory Affairs organization; set goals, allocate resources, manage budgets and establish metrics and processes that align with business objectives.
- Provide senior regulatory leadership for audits, inspections, escalations, field actions and compliance issues; maintain the highest standards of ethics, regulatory compliance and patient safety.
Where you'll work
Kennesaw, GAOn-siteOpen in Maps (opens in a new tab)
More jobs in Kennesaw, GAFrom the posting
About Artivion
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $209,500 | $235,000 | $264,000 |
Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Artivion's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions10
- Collaboration and leadership10
- GMP and compliance6
- Documentation and SOPs2
- Quality systems and risk2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
Company hiring pulse
Artivion on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Regulatory2 50%
- Quality2 50%
By level
- Director1 25%
- Manager1 25%
- Senior & Principal1 25%
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Senior Director, Regulatory Affairs - Product Development at Artivion
Open until filled.