Sales & Business Development Specialist

Key Responsibilities:

• Engage with medical device companies to understand their regulatory pathways, certification needs, and readiness for CE/MDR compliance.
• Provide guidance on conformity assessment routes, QMS requirements (ISO 13485), technical documentation expectations, and product classification.
• Communicate effectively with regulatory, quality, and engineering teams at client organizations.
• Support client preparation by explaining documentation requirements, validation expectations, and applicable standards.
• Participate in discussions regarding risk management (ISO 14971), usability engineering (IEC 62366), and product testing requirements.
• Generate leads and schedule meetings through email, phone, LinkedIn, and industry channels.
• Build and maintain strong relationships with medical device manufacturers, regulatory affairs teams, and quality leaders.
• Represent the company at trade shows, regulatory conferences, MDR/IVDR training events, and industry seminars.
• Manage the full sales cycle, including needs assessment, proposals, negotiation, and closing.
• Track KPIs, pipeline progress, and client interactions in the CRM.
• Collaborate with internal regulatory and auditing teams to ensure accurate communication of requirements and seamless client onboarding.
• Assist in preparing technical-oriented marketing content such as whitepapers, webinars, regulatory updates, and MDR guidance summaries.
• Conduct competitive and market analysis within regulatory compliance and Notified Body sectors.
• Gather client feedback to improve service offerings, technical explanations, and communication materials.
• Other related duties may be assigned from time to time.

Requirements:

• Bachelor’s degree in Biomedical Engineering, Regulatory Affairs, Quality Assurance, Life Sciences, or a related field.
• Minimum 1–2 years of experience in medical device regulatory affairs, quality assurance, compliance, auditing, validation, or certification support.
• Working knowledge of CE/MDR, ISO 13485, conformity assessments, risk management, and technical documentation requirements.
• Experience interacting with a Notified Body, FDA, or regulatory consultants preferred).
• Understanding of validation and verification activities, product testing, and clinical evaluation requirements (a plus).
• Strong communication and relationship-building skills.
• Comfortable with outreach via email, phone, and professional networks.
• Ability to work both in-office and remotely.
• Proficiency with office software, CRM tools, and documentation management systems.
• Valid driver’s license and ability to travel locally as needed.