Regulatory Affairs Senior Specialist

Benefits

Parental leave

Not verified

Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

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Salary

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function

Operations From the posting source checked Jun 20, 2026

Seniority

Senior From the posting source checked Jun 20, 2026

Schedule

Shift type

Not verified

Weekend work

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Company

Company stage

Public-company From the posting source checked Jun 20, 2026

Equity

Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter

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Assessment

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Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Regulatory Affairs Senior Specialist Location not specified At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. What You Can Expect 膝関節（Knee）、四肢（Extremity）、バイオロジクス（Biologics）、外傷領域（Trauma）など、多岐にわたる製品群の薬事戦略に携わることができます。 PMDA対応や承認申請だけでなく、保険収載・市場アクセスまで一貫して関与できるポジションです。 日本のマーケティングチームやMarket Accessチーム、海外RAチームと連携しながら、グローバル環境で経験を積むことができます。 RA Managerのサポートに加え、次世代メンバーの育成にも関わるため、リーダーシップを発揮できる環境です。 新製品導入や変更管理、QMS対応など、薬事として幅広い業務経験を積むことができます。 How You'll Create Impact Knee、Extremity、Biologics、Trauma製品における薬事申請・保険戦略を立案し、日本市場への導入を推進します。 PMDAやBSI向けの申請資料・STED作成を行い、承認取得までのプロセスを主導します。 海外RAチームと連携しながら、製品申請・承認プロセスを円滑に進めます。 Change Controlや文書開示プロセスを管理し、薬事コンプライアンスを維持します。 保険申請やClass I製品登録を通じて、製品の市場アクセスを支援します。 QAチームと協働し、QMS適合性調査やFMA対応をサポートします。 RA Managerやチームメンバーを支援し、組織全体の薬事機能強化に貢献します。 What Makes You Stand Out 医療機器業界における豊富な薬事経験を有している方 PMDA対応や医療機器申請業務を主体的にリードした経験 戦略的思考を

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