Regulatory Affairs Associate
Synectics Inc., North Chicago, IL, United States
Job Descriptions
Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s).
May assist Enhancement Leads to triage and disposition enhancement requests.
Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
Support relevant complex and/or cross-functional initiatives as needed.
May lead or co‑lead straightforward, departmental process improvement activities.
May be responsible for generating regulatory planning metrics, reports, and/or other system‑related needs.
Assist in system‑related training and/or updates to training material / logistics.
Qualifications
Bachelor's degree desired
RAC Certification from the Regulatory Affairs Professionals Society (RAPS)
Higher education and/or RAC certification may compensate for years of experience. Years of experience may also compensate for lower education.
2+ years of med device/pharmaceutical or industry‑related experience
Experience working in a complex and matrix environment
Strong oral and written communication skills
Experience / understanding / use of software tools
Keen awareness of cultural nuances / Proven ability to work in a global environment
Strong attention to detail and problem‑solving skills
Experience in Regulatory Affairs and/or Project Management preferred but may consider related area
Understanding of global regulations
MS Project experience preferred
Benefits
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s).
May assist Enhancement Leads to triage and disposition enhancement requests.
Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
Support relevant complex and/or cross-functional initiatives as needed.
May lead or co‑lead straightforward, departmental process improvement activities.
May be responsible for generating regulatory planning metrics, reports, and/or other system‑related needs.
Assist in system‑related training and/or updates to training material / logistics.
Qualifications
Bachelor's degree desired
RAC Certification from the Regulatory Affairs Professionals Society (RAPS)
Higher education and/or RAC certification may compensate for years of experience. Years of experience may also compensate for lower education.
2+ years of med device/pharmaceutical or industry‑related experience
Experience working in a complex and matrix environment
Strong oral and written communication skills
Experience / understanding / use of software tools
Keen awareness of cultural nuances / Proven ability to work in a global environment
Strong attention to detail and problem‑solving skills
Experience in Regulatory Affairs and/or Project Management preferred but may consider related area
Understanding of global regulations
MS Project experience preferred
Benefits
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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