- Assist with regulatory pathways and strategies, premarket FDA, and international regulatory submissions
- Assist with development and/or revision of Quality System procedures and processes.
- Assist with internal and supplier audit development, implementation, and execution
- Serve as a company representative during external audits by Regulatory and Third Party Auditors
- Design Control documentation assistance
- Validation and Testing Protocol Development
- Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements
- Bachelor’s Degree in Engineering, Science, or health-related field
- 2+ years’ related work experience in the medical device industry
- Working knowledge of FDA and other regulatory authorities
- FDA Regulatory submission experience (Pre-Submission, 510ks, PMAs, IDEs)
- International submission experience a plus
- Quality Systems development, implementation, and training experience
- Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
- Experience with Risk Management per ISO 14971
- Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
- Candidate must be a self-starter, self-motivated, and results oriented
- Excellent interpersonal and written communication skills
- Must be able to work independently and have ability to work with cross-functional teams
- Extensive project management skills with the ability to work under tight timelines and able to multi-task
We are currently seeking a self-motivated, charismatic individual to join our sales and marketing team to help further expand our footprint in the medical device industry. A successful candidate for this position possesses exceptional networking skills, is driven, and really thrives in seeking new business relationships. The ability to leverage current sales strengths and strive to exceed performance and expectations is highly desired. This individual will have direct support from leadership through training, dual participation in client meetings and conference attendance to cultivate success. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you excel at building mutually beneficial business relationships, optimizing growth and client satisfaction, and like the ideas of having independence, full leadership support that leads by example, while working in a transparent and positive culture that promotes professional growth, we’d love to hear from you.
- Represent and promote the organization with presentations about various services provided, including medical device development, engineering, regulatory affairs, and quality management systems
- Identify and create partnerships that enable leverage for driving revenue and increase marketing and branding
- Continuously prospect and set up appointments/presentations to achieve sales goals utilizing cold calling, LinkedIn, and other research/marketing methods
- Keep leadership informed by submitting activity and results reports, such as call reports, weekly work plans, and monthly and annual analyses
- Resolve client needs by investigating concerns, developing solutions, preparing reports, and making recommendations to management
- Maintain professional and technical knowledge by attending educational workshops; establishing personal networks; participating in professional societies
- Prepare for and attend conferences/trade shows to engage new client prospects
- Travel ~20%
- Bachelor’s Degree in Business Administration, Life Sciences, Engineering, or similar discipline
- Minimum 5-7 years’ experience in Sales and/or Marketing with proven results of generating accounts and developing sustained relationships in the medical device or pharmaceutical industry, healthcare, or other large organizations
- Very comfortable in engaging and interacting with high level professionals including executive management, physicians, and medical device sales representatives
- Ability to multi-task, prioritize, take ownership of duties, and work well under deadlines
- Possess excellent closing skills and understand how to take short and long sales cycles to closure with timing, follow up, and true professionalism
- Ability to simultaneously manage multiple accounts efficiently with appropriately timed follow up and client communication
- Identify and track metrics to adjust sales activity accordingly
- Advanced email correspondence/writing skills that are methodical and articulated
- Quick with technology, spreadsheets, PowerPoint presentations, Salesforce, Constant Contact, and LinkedIn.
- Technical knowledge and background on Medical Devices, Product Development, FDA, ISO, and other regulation requirements a plus.
- Coordinate sales and marketing initiatives.
- Conduct research to identify potential clients and contacts within each organization.
- Support client relations and account management activities.
- Facilitate new client information to accounting and engineering departments.
- Coordinate client meetings, conferences, and travel arrangements.
- Assist with special projects, such as proposal development and event marketing.
- Develop suitable marketing material.
- Update social media and website content.
- Bachelor’s Degree in Marketing, Business, Communications, or Advertising
- 1-3 years’ related work experience in the medical device, healthcare, or pharmaceutical industries
- Solid computer skills, including Excel, PowerPoint, Word, and Outlook/Gmail
- Experience with marketing automation/CRM solutions (e.g., Pipedrive, Salesforce, Constant Contact, HubSpot).
- Experience with WordPress or other website providers a plus.
- Excellent written, verbal, and interpersonal communication skills.
- Strong analytical, project management, and organizational skills.
- Resourceful, self-motivated, and able to work autonomously and proactively.
- Strong problem-solving skills.