Hi, I’m
Swasita Saigal
Vice President| General Manager
North Ridgeville,OH
Summary
Results-driven executive with extensive experience in strategic leadership and operational excellence. Proven track record in driving growth, optimizing processes, and fostering team collaboration. Exceptional skills in strategic planning, financial management, and stakeholder engagement. Adaptable and reliable, consistently achieving high-impact results in dynamic environments.
Overview
20
years of professional experience
1
Certification
Work History
Exsurco Medical Inc.
Vice President & General Manager
12.2023 - Current
Job overview
- Lead the team to grow the business by 20%, far outpacing the 6% CAGR for the surgical device market.
- Lead the overall sales strategy and providing direction to the sales team, ensuring that our objectives were aligned with the company’s goals. This included setting sales targets, pipeline management, adjusting tactics and strategies.
- Oversee the daily operations of the company to ensure efficiency, quality, and profitability.
- Streamlined and improved operational processes to enhance productivity.
- Ensured compliance with all legal, regulatory, and internal policies.
- Developed and managed the company’s budget, ensuring financial goals are met.
- Monitor cash flow, expenses, and revenues to keep the company financially healthy.
Exsurco Medical Inc.
Vice President, Technical Operations & Compliance
12.2020 - 12.2023
Job overview
- Created and rolled out defined processes in these work-streams (where currently processes did not exist).
- Partnered with other senior management to develop short and long term lean strategies and implemented these strategies.
- Led a CEO appointed project (January 2021-December 2021) to implement business and quality management systems aligned to ISO 9001 at a sister company to promote sustainable growth.
- Assembled a cross-functional team from multiple business units for project.
Exsurco Medical Inc.
Sr. Director, Technical Operations & Compliance
01.2020 - 12.2020
Job overview
- Led strategic planning and execution to enhance profitability, productivity and efficiency throughout the company’s operations.
- Partnered with multiple stakeholders and leadership to establish strategic visions, operational objectives, and procedures throughout the company.
- Led and achieved the Unique Device Identifier (UDI), Phase 1 (labelling) compliance program for regulated product.
- Executed application for NorthCoast 99 top workplaces in Northeast Ohio and Company was selected for 2020.
Exsurco Medical Inc.
Director of Regulatory Affairs and Corporate Compliance
02.2017 - 01.2020
Job overview
- Supported the company-wide goals and other Corporate Process Owners as a business lead for Regulatory Affairs.
- Developed and supported training for global regulatory processes and system implementations.
- Prepared product regulatory submissions in support of commercialization and business objectives as applicable.
- Co-executed GLP studies for device.
- Co-executed Human Factors validation for device.
- Managed consultants and their contracts for assigned regulatory and quality projects.
- Interfaced with industry professionals inside and outside of Exsurco Medical to identify best practices.
- Ensured new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
- Responsible for development, implementation and managing maintenance for TrackWise and other Software systems as applicable.
- Manage development of Exsurco QMS with Quality Manager to ensure that standards required are achieved.
- Developed and implemented Strategic Compliance Plan as well as action plans for advancing compliance initiatives.
- Authored procedure and Code of Ethical Conduct.
- Developed and maintained reports on compliance efforts to the Board and senior management on a regular basis.
- Managed relationship with AdvaMed.
Exsurco Medical Inc.
Regulatory Affairs Manager
04.2015 - 02.2017
Job overview
- Authored Procedures for launch of new 21 CFR 820 and ISO 13485:2003 compliant Quality System.
- Project lead for implementation of Track Wise
- Led cross-functional team to implement Complaints, CAPA, NCE and Supplier quality workflows.
- BARDA (government funding)
- Assisted in submission for BARDA white paper.
- Project lead for implementation of Software Validation per 21 CFR part 11
- Assisted in developing Clinical Affairs and Health Economic Strategy for Strategic Plan.
Invacare Corporation
Manager, Correction & Removals, Post Market Regulatory Affairs
07.2014 - 04.2015
Job overview
- Established and maintained complete Pre CRT (Corrections and Removals) and CRT files and database for all escalations according to FDA guidelines and internal regulatory compliance requirements.
- Managed Pre- CRT and CRT meeting workflow process of escalations within Invacare’s Corporate Quality System.
- Managed all escalations for next step decisions within timeframes dictated by FDA regulations and guidelines and internal regulatory requirements.
- For incoming CRT requests, collected and analyzed data from cross-functional resources and consolidated to provide a comprehensive objective view of the situation for review and final decision by pre-CRT and CRT teams.
- Communicated with Quality Department as to the status of Pre-CRT and CRT escalations within timeframes dictated by internal SOP’s.
- Managed review of complaint trending, sales and manufacturing data, DHR’s as required specific to escalated CRT requests.
- Managed gathering of additional supplementary information relevant to escalation to ensure sufficient data is present for Executive Management Team to make Correction and Removal decisions.
- Coordinated with Clinical staff to assure timely and complete Health hazard evaluations
- Worked closely with cross-functional (various groups) that have opportunity to impact investigation outcome (i.e. Engineering, Operations, Quality, Commercial, etc.)
- Provided communication on all Open/Closed Recalls and status of all escalations to CRT for Executive Management Review.
- Managed workflow process of recalls (correction, removals, withdrawals and stock recoveries) within Invacare’s Corporate Quality System. This includes creation of the recall strategy, direct communication with FDA district recall coordinator, creation of customer communications, management of sub-recalls as requested by customers and closure of recalls with FDA.
- Subject matter expert for FDA and third party audits and other roles as needed (i.e. back room administrator).
- Up to date of new and revised FDA policies, guidance and procedures to ensure compliance with requirements.
Invacare Corporation
Regulatory Affairs/Quality Assurance Analyst
12.2012 - 07.2014
Job overview
- Working knowledge of 21CFR Part 806
- Compiled and submitted all reporting to FDA and Health Canada
- Developed recall strategy
- Prepared and managed all internal and external communication on recalls
- Trained Customer Service, Technical Services and Sales on recall strategy
- Coordinated team meetings for timely execution
- Monitored execution and effectiveness of the recall
- Supervised recall database from a third party vendor
- Maintained current knowledge regarding applicable US regulations, guidelines, and customer practices
- Verified and revised applicable corporate procedures as required
- Participated as required in meetings, conferences with FDA
- Conducted training and managed training records on procedural changes
- CRT (Corrections and Removals Team)
- Documented minutes and decisions at CRT meetings
- Managed CRT electronic log binder
- Reviewed new Event review records bimonthly with Director of Regulatory Affairs to determine if additional information (HHE, investigation or additional statistical information) is required to proceed with CRT meeting.
- Conducted Investigations if required.
- Prepared required documentation for CRT review and coordinate completion of respective forms
Invacare Corporation
Consumer Affairs Specialist
01.2010 - 12.2012
Job overview
- Implemented new inventory system for product storage on pre-litigation files.
- Authored a reference guide for Consumer Affairs.
- Implemented electronic filing system for Consumer Affairs.
- Manage investigation on all pre-litigation (adverse event) complaint files; BBB, AG& Consumer Protection
- Ensure limited risk/exposure for the company while enhancing customer satisfaction.
- Collaborate with all required departments to establish a thorough investigation.
- Manage process supports (credits, returns, disposition of product) on complaints.
- Negotiate settlements with consumers, attorneys, and insurance carriers.
- A CA/PA team member
- Working knowledge of 21CFR 820, 21CFR Part 803 & ISO13485
Education
University of PhoenixPhoenix, AZ
Master of Business Administration from Healthcare Management
01.2011
John Carroll UniversityUniversity Heights, OH
Bachelor of Arts from Communications
01.1996
Skills
- Highly organized, directed and detail-oriented
- A clear straightforward communicator
- Thrive in deadline-driven environments
- Excellent team-building skills
- Proficient in Microsoft Project, Oracle, TrackWise, SharePoint, SyteLine- Infor, BarTender (labeling software)
- Relationship building
- Coaching and mentoring
- Complex Problem-solving
- Client relationship building
- Strategic planning
- Business development
- Results-driven
Certification
- The Art &Science of Leadership, Ratliff & Taylor 2017
- ASQ- CQA Certificate no. 66601, Expires 2023.
- RAC certificate completed (2016)
- Intermediate Medical writing: Medical Devices (RAPS online university- July 2013)
- Certificate in CAPA- Managing Effective CAPA projects through Pathwise (2012)
- Certificate in Complaint Handling & Investigation through Pathwise (2012)
Affiliations
Erie Country Economic Development Corporation: Board of Directors- 2019
Timeline
Vice President & General Manager
Exsurco Medical Inc.
12.2023 - Current
Vice President, Technical Operations & Compliance
Exsurco Medical Inc.
12.2020 - 12.2023
Sr. Director, Technical Operations & Compliance
Exsurco Medical Inc.
01.2020 - 12.2020
Director of Regulatory Affairs and Corporate Compliance
Exsurco Medical Inc.
02.2017 - 01.2020
Regulatory Affairs Manager
Exsurco Medical Inc.
04.2015 - 02.2017
Manager, Correction & Removals, Post Market Regulatory Affairs
Invacare Corporation
07.2014 - 04.2015
Regulatory Affairs/Quality Assurance Analyst
Invacare Corporation
12.2012 - 07.2014
Consumer Affairs Specialist
Invacare Corporation
01.2010 - 12.2012
University of Phoenix
Master of Business Administration from Healthcare Management
John Carroll University
Bachelor of Arts from Communications
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