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Regulatory Affairs Specialist

Req ID:  2062

Working Location: MASSACHUSETTS, WESTBOROUGH 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Specialist European Union Regulatory Affairs will support the regulatory submissions relating to the European Union including updating and maintaining the EU technical files and supporting documentation to ensure they are compliant with the MDD (93/42/EEC) and supporting the Engineering R&D and other functions on matters relating to EU compliance.

Job Duties

 * Maintain and update Gyrus ACMI's EU Technical Files so they remain compliant with current regulatory and company standards Maintain and update the clinical evaluation documentation to support EU and international regulations.

 

* Train and advise personnel in Engineering R&D and regulatory functions to ensure awareness of EU requirements.

 

* Review new standards and regulations as they are issued to determine how they affect Gyrus ACMI products.

 

* Work with engineering and technical personnel to ensure continued compliance to any revised referenced standards.

 

* Participate in the development and review of quality system procedures as they relate to EU compliance.

 

* Participate in regulatory agencies inspections and responses to any findings that may result.

 

* Support manufacturing engineering quality assurance product development and clinical affairs as required to ensure regulatory compliance.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree preferably in engineering or life sciences or equivalent years of experience.

 

* Regulatory experience in the Medical Device industry or equivalent degree.

 

* Minimum of 5 years Regulatory compliance experience in the Medical Device industry with a Bachelor's degree is required' Minimum 3 years with a Master's degree is preferred. 

 

PREFERRED QUALIFICATIONS:

 

* Minimum of 3 years Regulatory experience in the Medical Device industry preferred.

 

* Must be able to communicate effectively (verbal and written).

 

* Must be proficient in Microsoft Office (Word Excel or Access PowerPoint).

 

* Ability to work in small team environment but also self-starter with ability to work independently.

 

* Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.

 

* Must be able to meet deadlines and be detail oriented. Good planning and organization skills a must.

 

* Strong critical thinking and problem solving skills. Strong knowledge of MDR requirements required.

 

* Documented continuing education in regulatory affairs RAC Certification is a plus.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Engineer, QA, Quality Assurance, Manufacturing Engineer, Engineering, Quality, Technology

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