What are the responsibilities and job description for the Senior Regulatory Affairs Operations Specialist — Medical Device (Hybrid — Marlborough, MA) Contract position at Pharmavise Corporation?
Overview:
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp
Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Regulatory Affairs Operations Specialist.
Job Summary:
The Senior Regulatory Affairs Operations Specialist will lead activities to drive alignment and consistency across the Endoscopy RA Organization, throughout the product lifecycle. Working closely with functional leadership, this position will focus on continuous improvement of Endoscopy RA data, processes, systems, and documents, and support projects to drive standardization and automation.
Responsibilities:
- Researching and documenting 510(k) history, including but not limited to:
o Generate a clearance/approval chronology in a prescribed format for each commercial device, verifying the 510(k) to product linkage as well as applicable Letters to File
o Verifying FDA Product Codes for all 510(k) exempt devices
o Reformatting regulatory data into a prescribed format for system upload
- Organizing paper and electronic 510(k) documentation in a prescribed format
- Monitor for changes to collected data to ensure data integrity
- Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed
- Support RA systems, processes, and business process to improve the overall effectiveness of the Endoscopy Regulatory Affairs function
- Maintain regulated data for Endoscopy using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc.
- Support and maintain Quality initiatives in accordance with Quality Policy
- Continuously assess ways to improve Quality
Required Qualifications:
- A minimum of a Bachelor’s degree in a scientific, technical, or related discipline
- A minimum of 5 years of experience in Regulatory Affairs within the medical device industry
- Working knowledge of FDA and international regulations for medical devices
- General understanding of product development process and design control
Preferred Qualifications:
- Ability to manage several projects of moderate scope and complexity
- High attention to detail, task oriented, deadline conscientious
- Proficiency in Microsoft Excel with ability to convert data for more effective analysis
- Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel
- Effective research, analytical, and problem-solving skills
- Effective written and oral communication, technical writing, and editing skills
- Ability to work independently with minimal supervision
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy
Other Details:
- Schedule: 40 hours per week
- Contract Length: 6 months
- Work Setup: Hybrid in Marlborough, MA (3 days onsite, 2 days remote)
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
