At HYCOR we believe you should LOVE WHAT YOU DO.
Were looking for innovators who strive to make a difference. We care about our people and our industry of improving the health wellbeing and quality of life of individuals with allergic conditions. So come join us if you do too!
What Youll Be Doing
The Regulatory Affairs Manager has a managing role in the planning coordination and of Hycors 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 (PreSub 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 DCCs 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
- Supportcommercialization 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
What Youll Bring to The Table- Bachelors 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 crossfunctional 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 interorganizational meetings
- Ability to perform work with minimal direction and supervision
- Ability to provide solutions to difficult technical issues associated with specific projects
Preferred Skills:- 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.
Whats in It For you
You will get to make an impact! Experience the culture of a small familyfeel innovative startup with a 40year history. Be a part of handson 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 Companys existing line of HYTEC products. The company is focused on delivering NOVEOS a new generation fullyautomated allergy system that solves the shortcomings of todays technology with 1/10th the sample requirement and negligible interference issues.
Required Experience:
Manager