Job Description
Job Description
For over 160 years, Haag-Streit has been a leading provider of medical equipment for ophthalmologists, optometrists, and opticians. Our experience is the foundation for developing, designing, and producing unparalleled medical instruments and equipment. From slit lamps to surgical microscopes, digital imaging to procedure chairs, we set the standard for precision mechanics and innovative technology. Haag-Streit USA, headquartered in Mason, Ohio is the USA manufacturing, distribution, sales, engineering and service operating facility for the Haag Streit and Reliance Medical lines of products.
The advantages of working at Haag Streit USA :
- Global Leader - Haag-Streit has been a leading provider of medical equipment for ophthalmologists, optometrists, and opticians for over 160 years.
- Strong sense of purpose – Our employees take pride in producing products that serve medical markets worldwide. Our high-quality exam and procedure chairs, surgical stools, instrument delivery systems, treatment cabinets set the standard for reliability and precision.
- Stability and innovation - Established over 160 years ago, Haag Streit and Reliance Medical Products experience is the foundation for developing, designing, and producing unparalleled medical instruments and equipment.
- What will you get in return?
Excellent benefits package that starts on the first day of the month after you are hired
Employee high deductible medical plan free to employees , no monthly premiumEmployee vision coverage free to employees , no monthly premiumAdditional plans and coverage tiers available at highly competitive ratesBasic life insurance and Short-Term disability provided at no cost to employeesAdditional benefits including Dental, Critical Illness, Long Term DisabilityPTO, Vacation, 12 Paid Company HolidaysBest in class 401(k) with company match and profit sharing, up to 8% employer contributionSUMMARY :
As the Regulatory & Clinical Affairs Manager, you will operate predominantly within the U.S. market and report directly to the Global Head of Clinical Affairs & Clinical Operations. You’ll collaborate closely with colleagues stationed in various Haag-Streit locations worldwide, guiding cross-functional teams through product development, compliance, and post-market activities. This role involves occasional domestic travel within the U.S. as well as occasional travel to other sites internationally, according to project and team needs.
ESSENTIAL FUNCTIONS :
Provide guidance and support in the application of regulatory and clinical strategies for the development, manufacturing, and marketing of compliant devices throughout the Haag-Streit Group.Coordinate project activities related to regulatory and clinical affairs.Maintain compliant processes and ensure compliance of associated document templates for regulatory requirements.Advise on regulatory and clinical requirements and strategies throughout the product life cycle.Review technical documentation, labelling and accompanying documentation for clinical claims and regulatory compliance.Conduct literature reviews and clinical evaluation.Prepare and submit documentation required for research study registration.Provide expertise for the maintenance of up-to-date risk files (safety / biocompatibility).Provide expertise for the analysis of post-market data, identification of trends and maintenance of post-market surveillance files.Keep professional knowledge of regulatory requirements for medical devices up to date through suitable measures such as attending courses, seminars and workshops and studying specific literature.Provide expertise for Corrective and Preventative Actions (CAPAs).Provide expertise for Field Safety Corrective Actions (FSCAs).Provide expertise for audits and inspections as required.KNOWLEDGE, SKILLS, AND ABILITIES :
Bachelor's degree in life sciences, pharmacy, or related field (preferred) with an advanced degree (MS, MD, PhD, or JD) also a plus.3-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on clinical trials.Knowledge of ISO 14155 / GCP, CFR 820 and FDA guidelines required.Knowledge of 2017 / 745 MDR and ophthalmology desirable.Technical or medical background preferable.Excellent English, written and oral required. Secondary language skills desirable.Knowledge of medical devices and understanding of medical and scientific aspects of products required.Data management & analysis : Management, analysis, and interpretation of complex data sets. Knowledge of statistical methods, study designs and methodology.Regulatory and legal understanding.Risk management : Application of risk management principles and methodologies to all tasks.Technical understanding for assessment of medical device technology.Auditing skills : Ability to conduct internal and external audits, including knowledge of audit planning, execution, and reporting, as well as monitoring of research studies.Ethical judgment and integrity : Advocate strong ethical standards, safeguard sensitive patient data, and ensure study participant safety.Organisation : manage assigned tasks or projects independently.Communication : convey complex concepts and issues clearly to co-workers and internal teams, as well as suppliers, regulatory bodies, authorities, and other stakeholders.Adaptability : flexibility to adapt to changing regulations and industry landscapes.Occasional travel within the USA, depending on project needs.Isolated travel to other sites, depending on team needs.Haag Streit USA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, genetic information, disability or protected veteran status.
If you are unable to apply online due to a disability, contact recruiting at hr@haag-streit-usa.com
