Our Company
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.
The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.
Summary
Responsible for managing the IVDR team including recruiting, performance management, and mentoring. Responsible for developing and implementing strategies for completing and submitting required technical documentation to Notified Body(s), Authorized Representatives, and Importers for obtaining registrations and clearance to market in the European Community and Switzerland. Collaborates within the team and with cross-functional team stake holders to ensure compliance to applicable regulations, standards, and the company’s quality management system and policies. Maintains knowledge of applicable global regulations and industry standards to ensure high standards of quality, safety, and effectiveness of BioCare’s’ products.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Manage the IVDR team including recruiting, performance management, and mentoring.
- Develop and implement a strategy for the submission of Technical Documentation for Biocare Medical products to the Notify Body (Class B to D).
- Submit of Biocare Medical Class A products technical documentation to the European Representative.
- Work with program management on deliverables per project plan and strategy for Technical Document development, update, and submission.
- Write technical documentation per IVDR requirements and route for review and approval.
- Update existing technical documentation files to be compliant under IVDR and for submission to Notify Body.
- Review and approve deliverables for technical files, such as verification and validation testing protocols and reports, post marketing surveillance reports, literature review reports, etc.
- Ensure on-time development and delivery of high-quality regulatory documents (Technical files, GSPRs, Gap Assessments, Risk management documentation, Literature Reviews, Post Marketing Surveillance, etc.) compliant with IVDR.
- Proactively manage relationships and communications with Competent Authorities, Notified Bodies, Authorized Representatives and Distributors. Ensure timely correspondence with Notified Bodies to obtain or maintain IVDR certification and successful submissions of technical documentation.
- Track and report status of regulatory affairs deliverables to management. Participate in management reviews.
- Support IVDR audits coordinating with Notify Bodies and Biocare Medical departments.
- Provide regulatory guidance to departments or development project teams regarding IVDR.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Actively contribute towards the company Regulatory culture and provide ideas on improving the efficiency and effectiveness of processes within the company.
- Other duties as assigned by Management.
Competencies
- Bachelor’s Degree with seven to ten (7 to 10) years experience working in regulated medical device/IVD or related industry is required.
- At least seven (7+) years experience in leadership and team management, including the ability to motivate, mentor, and develop employees is required.
- Hands on senior leader with significant experience working within the IVDD/IVDR field.
- Expert knowledge of the compliance requirements of IVD Directive 98/79/EC and/or IVD Regulation 2017/746
- Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP is a plus
- Demonstrates strong analytical, critical thinking, problem solving and investigative skills.
- Excellent interpersonal skills and the ability to work collaboratively with the wider team.
- Excellent organizational skills, attention to detail and an ability to work to tight timelines under minimum supervision.
- Excellent oral and written communication skills.
- Strong computer and internet research literacy with proficiency using Microsoft tools (Word, Excel, PowerPoint, Outlook)
Expected Location & Hours of Work
- This is a full-time on-site position.
- 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.
Compensation Range
- $120,000 - $160,000 annually
Full-Time Positions Offer
- Company Sponsored Health Insurance - medical, dental, vision,
- Company Sponsored Life Insurance
- Voluntary Benefits
- Retirement plan - 401(k)
- PTO
- Paid Holidays
BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.
Proof of at least one FDA EUA approved Vaccination for Covid-19 preferred. (Subject to reasonable accommodation)
All inquiries strictly confidential.
