The Johner Institute is a consulting, training, research, and software company with the mission to help medical device manufacturers navigate the often-complex regulatory approval process with various authorities worldwide, helping them to bring innovative and life-saving products to market faster. We also exist to serve as visionaries, challenging the status quo and offering innovative solutions that benefit the global medical device ecosystem, including regulatory agencies, medical device manufacturers, healthcare systems, and ultimately patients.
The primary responsibility of this position is to serve as a Trusted Advisor to our clients, leading their efforts to navigate US, EU and international medical device regulatory processes. This position requires utilization of US FDA and international regulations to develop procedures, regulatory strategies and submissions, agency correspondence and post-market compliance activities. On a daily basis you will interact with clients, prospects, suppliers, other consultants and experts within and outside of our global team in order to communicate and implement Johner Institute solutions for our clients.
Principal Duties and Responsibilities
On a full-time basis, you will enthusiastically take on the following tasks:
- Consult with clients to implement processes and procedures and conduct analyses to sustain and improve their regulatory processes, consistently striving for comprehensive and complete solutions while minimizing the time to market. Examples include:
- Defining and implementing regulatory and market access strategies
- Developing Risk Management plans
- Developing Quality Management Systems
- Preparing and/or reviewing regulatory submissions
- Developing audit plans, inspection methods and procedure development
- Define post-market plans and activities including complaint handling, MDR and IVDR evaluations, and CAPA assessments
- Responsible for effectively communicating with Johner Institute management and team members, clients, meeting client deadlines, and managing client expectations
- Use creative problem-solving skills to identify, solve, and/or improve processes and minimize barriers to success
- Work with suppliers, regulatory agencies, clients, and other group members to assist with implementation and effectiveness of client deliverables
- Review project plans, data, procedures, and test protocols/reports for accuracy and technical application of standards (ISO, AAMI, ASTM, IEC)
- Ensure compliance to US/FDA, EU/MDR, ISO, IEC, Federal, and other applicable national and international regulations on behalf of Johner Institute clients.
- Prepare, analyze, and submit regulatory documentation to domestic and international governing agencies
- Project manage regulatory projects for domestic and international medical device companies including FDA submissions (510(k), PMA, De Novo) and Technical Documentation/CE Mark submissions (EU MDR/ EU IVDR)
- Serve as Subject Matter Expert (SME) offering strategic direction and tactical support to clients in the international registration and approval of medical devices
- Develop regulatory strategies (including determining the correct classification, identifying regulatory requirements, or selecting the best approval pathway)
- Working closely with our business development team, you’ll participate in discovery calls/meetings with clients to gather requirements, offer guidance, establish credibility, and make sure that new client engagements launch successfully
- Prepare Statements of Work, estimate work efforts, assist with proposal development
- Develop technical documentations and submission files (e.g. EU and FDA), or serve as a mentor to clients by providing direction and guidance, and reviewing client-authored documentation
- Communicate with Regulatory authorities and Notified Bodies
- Work closely with us to further develop concepts for streamlined and efficient international regulatory affairs consultation
- Improve and provide input to our templates and software tools such as the Medical Device University (www.medical-device-university.com)
- Leveraging your industry experience, provide input on go-to-market strategies, service offerings, and contribute to maximize Johner Institute’s value proposition to the clients we serve.
Requirements and Experience
Education and Certifications
- Must possess a comprehensive knowledge and competency of medical device quality system regulations 21 CFR 820, ISO 13485, ISO 14971, EU MDR 2017/745, EU IVDR 2017/746, MDSAP, among others.
- Ability to apply logic, creativity, and scientific thinking to a wide range of intellectual and practical problems
- Must have experience working multiple opportunities/projects simultaneously with various sized companies, from start-ups to fortune 500 firms
- Possess excellent time management skills as well as strong written and verbal communication with Johner Institute staff, regulatory authorities, partners, and especially with our clients
- You enjoy developing and building long-term customer relationships thanks to your outstanding performance
- You have at least 10 years of professional experience in the field of international regulatory affairs - specific to medical devices
- You are familiar with the relevant regulatory requirements such as standards, laws and guidance documents and enjoy constantly expanding your knowledge,
- You are characterized by a polite and engaging manner, and you are confident in your knowledge, guidance, and direction.
- You proactively and openly communicate with internal and external stakeholders, taking the initiative to improve situations and for the betterment of everyone involved.
- You’re able to work independently and without direct supervision, as well as part of an extended team
- You take responsibility for your own results and thus for the success of the clients, the Johner Institute and yourself.
- You’re deadline driven, and able to work efficiently, independently, and as part of collaborative team
- Bachelor’s degree (or equivalent), Master’s degree preferred
- Regulatory Affairs certification and/or 10+ years of experience, with a specific concentration on Medical Devices
This is what sets us apart
With us, you will find yourself in a motivating atmosphere of appreciation and mutual support and encouragement. Together, we are on an exciting and dynamic path. We are growing fast and constantly developing - each of us individually as well as our company as a whole. Rigid, hierarchical structures, frustrating decisions by superiors, political games, and opaque, meaningless sets of rules do not exist at our company.
We place a high level of trust in our colleagues. We know that each of us will do our best and contribute with motivation and commitment. Here, we have absolute creative freedom and the opportunity to take on responsibility, make independent decisions, and constantly expand our knowledge.
What we offer
- Competitive salary and benefits in accordance with the market, including
- up to 30 days paid vacation
- up to 10 days sick leave
- Public holidays off
- Medical/Healthcare benefits
- Flexible working hours are a matter of course
- Professional development assistance
- Remote, Work from home
- Values that are truly lived
- Integrity and transparency
- Freedom of design and change
- Appreciation and motivating team spirit
Are you interested?
Then get in touch now and apply with us today! We look forward to receiving your resume/CV, as well as a cover letter introducing yourself. Please include your earliest possible start date and your salary expectations. Hiring for this position is a priority for us, and we want to move forward as quickly as possible.
Johner Institute is an Equal Opportunity Employer committed to a diverse workforce. Johner Institute will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, non-job related mental or physical disability, veteran status, military service, application for military service, or membership in any other category protected under law.
Richard Gordon Piquett
Johner Institute North America
9466 Georgia Ave PMB 2009,
MD 2090 Silver Springs
+1 (301) 244-6335