Manay CPA Accounting & Tax Services · 1 week ago
Sales & Business Development Specialist
Medford, MA
Full-time
Hybrid
Entry Level
1+ years expManay CPA Accounting & Tax Services is a globally recognized Notified Body providing medical device conformity assessment services. They are seeking a Sales & Business Development Specialist to engage with medical device companies, support their regulatory needs, and help expand the company's presence in North America.
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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
Qualification
Required
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
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
Preferred
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)
Company
Manay CPA Accounting & Tax Services
Manay CPA Inc.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Burcin Bella Sonmezer
Partner
Burcu Bree Manay - CPA
Managing Partner
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