Sales and Business Development Specialist
Manay CPA Accounting & Tax Services
full-time
Posted on:
Location Type: Hybrid
Location: Medford • Massachusetts • United States
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About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsquality assurancecomplianceauditingvalidationcertification supportrisk managementtechnical documentationproduct testingclinical evaluation
Soft skills
communicationrelationship-buildingoutreachcollaborationclient feedback gathering