SUMMARY OF ROLE: We are seeking a Director, Regulatory Affairs to join our growing medical technology company. This individual will be responsible for leading regulatory strategy and submissions for our products, managing post-approval compliance obligations, and supporting quality and other cross-functional organizations on post-market surveillance and MDR reporting to meet business expectations. The ideal candidate will have excellent people skills and a can-do attitude as well as a passion for working on a cutting-edge, life-saving product.

RESPONSIBILITIES:

• Serve as Regulatory Lead, representing the Regulatory Department on cross-functional teams.
• Develop and implement US and global regulatory strategies for PMA marketed products with AI/ML, including PMA supplements, Predetermined Change Control Plan (PCCP) and 510K pathways for accessory devices.
• Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact.
• Lead the organization and preparation of clear and effective regulatory submissions that align with company strategies and Health Authority requirements.
• Foster strong relationships with relevant regulatory agencies and key stakeholders while advocating for company positions.
• Lead interactions with regulatory agencies and health authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization.
• Effectively represent the Regulatory Affairs function to senior leadership at governance meetings.
• Lead the organization and preparation of clear and effective regulatory submissions aligned with business strategies and regulatory requirements.
• Lead preparation of PMA supplements, including but not limited to AI/ML updates, manufacturing changes, design changes in compliance with 21 CFR 814.
• Manage PCCP strategy and amendment lifecycle, including Q-Sub interactions with FDA for Real Time Review and other expedited pathways
• Lead regulatory submissions for clinical investigations (IDEs) and PMA Post Approval Studies (PAS), including annual reports, study modifications.
• Lead and manage the preparation of technical documents and dossiers for regulatory submissions.
• Ensuring ongoing compliance with regulatory requirements and managing up-to-date regulatory submission and correspondence files.
• Maintain Technical Files to meet state-of-the-art requirements; support EU MDR post-market documentation (CER, PMCF, SSCP) in coordination with Notified Body and external partners as applicable.
• Partner with engineering and commercial teams to assess software and digital health features against FDA software as a Medical Device (SaMD) and MDDS frameworks, determining applicable regulatory pathways.
• Evaluate labeling, promotional materials, and clinician-facing portals for regulatory compliance.
• Support the organization with MDR reportability determinations in coordination with Quality.
• Create a strong regulatory culture and share best practices across the broader organization.

QUALIFICATIONS:

• Science or Engineering background required (M.S. or B.S. with 10+ years of regulatory experience) in medical device with at least 5 years focused on class III PMA products.
• Proven ability to represent Regulatory on project teams and at Health Authority meetings.
• Demonstrated strategic thinking skills, sound judgement, and ability to integrate strategies into actionable plans.
• Strong knowledge of U.S. FDA Class III device regulations, PMA lifecycle management (supplements, PCCPs, PAS), and post-approval compliance obligations under 21 CFR Parts 803, 806, and 814; working knowledge of EU MDR and international frameworks a plus.
• Direct experience with AI/ML-enabled medical devices, SaMD regulatory strategy, or predetermined change control frameworks strongly preferred.
• Familiarity with DME distribution models and associated regulatory considerations (Medicare/CMS coverage, HCPCS coding, supplier standards) is a plus.
• A thorough understanding of the development process and working knowledge of the essential activities for all key functional areas.
• Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely.
• Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals.
• Capable of project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk.
• Able to work independently on competing priorities in a fast-paced and dynamic environment, a creative thinker with good attention to detail.
• Established credibility with U.S. FDA (CDRH), including experience navigating Q-Sub/Pre-Sub meetings, deficiency letter responses, and informal FDA interactions; Notified Body experience a plus.
• Evidence of technical knowledge to foster scientific credibility with regulatory agencies.
• Appreciation for quality systems, risk management, and medical product development.

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $195,000 - $240,000

BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science.