Analyst II, Global MDR Submissions

Req ID: 9992

Working Location: NATIONWIDE

Workplace Flexibility: Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. 

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Job Description

As a Global MDR Submission Analyst II OSTA team member, you will be responsible for timely regulatory reporting assessments and reassessments of global complaints, preparation and submission of initial/importer/supplemental MDR reports for post market activities per 21CFR803. Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly. Performs routine assignments with minimal direction from manager; requires general instruction for new or special assignments from Manager. The Analyst II will maintain quality documents to ensure compliance with global medical device guidance documents. The Analyst II requires working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803

Job Duties

Review incoming complaints to determine the facts of the case.
Verify information including information available in ancillary systems data sources. (For example: Datasweep, SAP)
Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly.
Conducts timely initial MDR reportable assessment/ submission per 21CFR803.
Conducts timely re-assessments when new information has been received to determine if an initial or supplemental MDR is required per 21CFR803.
Assist with preparation and submission of FDA Additional Information responses, and associated documentation to the FDA and Manufacturing Business Centers (MBCs).
Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.
Key Team player working closely with other Global MDR Submission Associates
Perform other duties as assigned

Job Qualifications

Bachelor of Science degree with 1-3 years medical device experience or Associate degree with scientific discipline,or License Practical Nurse (LPN) with 3-5 years medical device experience (i.e. LPN, Associate RN, X-Ray technician, Biomedical technician) Complaint Handling/ Customer Service experience in the Medical Device/ Pharmaceutical required.
Must be able to maintain good attendance regular scheduled hours.
The ability to read, write and communicate effectively in English is required; includes clear, understandable speech and demonstrated comprehension skills.
Must be able to follow standard practices and procedures.
Attention to detail and accuracy required.
Strong analytical and organizational skills required.
Must be able to prioritize workload in order to meet regulatory/ procedural deadlines.
Basic knowledge of medical terminology and human anatomy.
Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485,21CFR820, and 21CFR803.
Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.
Knowledge/ ability to utilize various software/database sources.
The ability to collaborate and be a team player.
Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $73,671.00 - $99,456.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

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 || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: Worcester
Job Segment: Pharmaceutical Sales, QA, Quality Assurance, ERP, Sales, Quality, Technology

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