At HYCOR we believe you should LOVE WHAT YOU DO.
We’re looking for innovators who strive to make a difference. We care about our people and our industry of improving the health, well-being and quality of life of individuals with allergic conditions. So, come join us if you do too!
 
What You’ll Be Doing
The Regulatory Affairs Manager has a managing role in the planning, coordination, and execution of Hycor’s global regulatory submissions.  The individual must have excellent organizational skills, excellent verbal and written communication skills, have the ability to lead, motivate, and support internal and external teams and have IVDR regulatory affairs operational skills, and compliance requirements experience.  The Regulatory Affairs Manager must have knowledge of applicable regulations and guidelines under both FDA (USA), and EU (European). Other international requirements knowledge is a plus.
 

• Lead by induvial contribution, and direct a team to prepare regulatory submissions and filings required for U.S. FDA and other international authorities (Pre-Sub, 510(k), CE technical documentation, DOC, MDR, IVDR, Vigilance Reports, etc.)
• Create, or gather technical documentation (Tech and or STED files) to support EU and International medical device registrations
• Act as member of project teams, and in many cases lead projects for the teams
• Determine regulatory needs for new products and changes to existing products
• Review labeling and marketing materials for compliance with regulations
• Review DCC’s and other controlled documents, including approval of these
• Participate in inspections/audits by the notified body or other international agencies
• Support MDR, vigilance and recall related activities, including HHE, and determining recall or field corrections class
• Develop and refine regulatory processes and procedures
• Support commercialization activities for product lines globally, and know requirements
• Review and Approve DOCs (Declaration of Conformity) for CE marking
• Perform other duties, as required or assigned

• ​​​​​Bachelor’s Degree in Science or Medical Technology
• Regulatory Affairs Certification (RAC) is a plus. (RAPS)
• Minimum of 10 years of experience in diagnostics, life science, or medical devices, biotech, or pharma with a minimum of 5 years in regulatory affairs, and 3 years in a Manger role
• IVDR experience, with Allergy background a plus
• Demonstrated ability to successfully support FDA submissions
• Demonstrated ability to work successfully on cross-functional teams
• Good knowledge of regulations such as CFR 820, IVDR, IVDD, ISO 13485, and Quality System Regulation
• Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971
• Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars
• Have strong planning, organizational, and communication skills
• Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat etc.
• Ability to manage both people and projects. Mentor as needed and have excellent judgment, attitude, and be customer oriented.
• Must be available and willing to work flexible schedules, as needed
• Must be able to travel, up to 15%
• Ability to work independently
• Ability to manage projects and people
• Excellent oral, written, organizational, and analytical skills
• Understanding of IVD/IVDR products, immunoassays, instruments and software
• Ability to represent the regulatory affairs department in frequent inter-organizational meetings
• Ability to perform work with minimal direction and supervision
• Ability to provide solutions to difficult technical issues associated with specific projects

• Prior experience with FDA submissions
• Strong working knowledge of problem solving and statistical methods, as applied to data included in regulatory submissions
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or regulations
• Ability to independently. Solutions must be thorough, practical, and consistent with organization objectives.

What’s in It For you
You will get to make an impact! Experience the culture of a small, family-feel, innovative start-up with a 40-year history. Be a part of hands-on decision making and take full ownership of your position.

Our HYCOR family is truly excited about the importance of our work, and we enjoy being a part of this company plus we have some nice perks like a choice of affordable, comprehensive health insurance plans for the whole family, a 401k matching plan, Paid Time Off, an alternative 9/4 work hours workweek and more.
 
About Us
Founded in 1981, HYCOR Biomedical, is a global manufacturer and marketer of in vitro diagnostic products. Since its founding, HYCOR has served the allergy diagnostic testing needs of clinical laboratories, hospitals and doctors' offices worldwide. The recently launched NOVEOS™ builds upon 40 years of experience in specific IgE testing, and supplements the Company’s existing line of HYTEC® products. The company is focused on delivering NOVEOS, a new generation fully-automated allergy system that solves the shortcomings of today's technology, with 1/10th the sample requirement and negligible interference issues.