Job Description
Job DescriptionCompany Overview:Our client is a globally recognized Notified Body approved by the European Commission, providing CE/MDR and other medical device conformity assessment services that enable manufacturers to access the European market. Renowned for its technical expertise and trusted reputation, the company is expanding its presence in North America.
As part of this growth, the company is seeking a Sales & Business Development Specialist with strong knowledge of medical device regulatory, certification, and validation processes. This role is ideal for candidates who understand CE/MDR requirements, quality management systems (ISO 13485), and medical device compliance pathways—and are excited to bridge technical knowledge with business development.
This position offers the opportunity to work closely with regulatory experts, support manufacturers through complex certification processes, and play a critical role in expanding the company’s North American footprint.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.
Apply now and be part of our valued client's growing success story in North America.
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