Regulatory Affairs Specialist

Regulatory Affairs Specialist (Submissions Focus) Experience Level: 2-5 Years Role Overview We are seeking a driven Regulatory Affairs Specialist to spearhead our global market access strategy. This is a high-impact role focused on the pre-market lifecycle of medical devices. You will be responsible for independently authoring and managing complex submissions to the FDA, maintaining EU Technical Files, and coordinating international registrations through our global network of distributors and sponsors. Important Note on Fit: This is a Submissions/Pre-Market focused role. Candidates whose experience is primarily restricted to Post-Market Surveillance (PMS, PSUR, PMCF), Clinical Evaluation Reports (CER), or Complaint Handling will not be considered suitable for this specific opening. Key Responsibilities 1. Global Submissions & Authoring Independent Authoring: Prepare, write, and submit high-quality regulatory filings, including FDA 510(k)s , De Novos, or PMAs. EU Technical Documentation: Independently author and remediate EU MDR Technical Files and Design Dossiers. Declarations of Conformity: Create and maintain DoCs in compliance with evolving global standards. 2. International (OUS) Market Access Distributor & Sponsor Management: Partner with OUS distributors, importers, and local sponsors to facilitate product registrations in diverse international markets. Document Strategy: Identify and compile the specific technical documentation packages required for regional registrations (STED, Dossiers, etc.). 3. Compliance & Lifecycle Management Labeling Excellence: Review and approve product labeling, IFUs, and marketing collateral to ensure compliance with global regulatory requirements. Change Control: Lead Regulatory Change Impact Assessments to determine the effect of design or manufacturing changes on existing clearances and registrations. eQMS Navigation: Utilize electronic Quality Management Systems (eQMS) for document control, approvals, and maintaining the Regulatory History File. Required Qualifications & Skills Requirement Description Experience 2-5 years of direct Regulatory Affairs experience in the Medical Device industry. Submissions Proven track record of independently authoring full FDA submissions and EU Technical Files. OUS Knowledge Practical understanding of the documentation flow between manufacturers, importers, and distributors for global registrations. Standards Strong working knowledge of ISO 13485 and EU MDR 2017/745 . Assessment Ability to perform critical thinking for change impact assessments and labeling reviews.