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Regulatory Affairs Operations Specialist

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Qualifications:

Bachelor's Degree in life sciences or related field, 2+ years of Regulatory Affairs experience, Strong administrative support background, Preferred RAPS (RAC) Certification.

Key responsabilities:

Support regulatory intelligence activities
Collaborate with cross-functional teams

LanceSoft, Inc. XLarge https://www.lancesoft.com/

1001 - 5000 Employees

See more LanceSoft, Inc. offers

Job description

Job Title: Regulatory Affairs Operations Specialist
Location: Remote (Looking for someone preferably in EST)
Duration : 6 Months with possible extension

Job Description:

Min. 2 years of administrative support experience with at least 1 of those years in the regulatory admin support space.
The experience should be professional and not during internship.
Must have strong communication skills.
Regulatory Ops support experience
Regulatory Intelligence is a plus
Change Assessment experience a plus
Excellent Office 365 experience
Heavy work within Excel and Smartsheets
Any PLM experience is strongly preferred
Any ERP experience is strongly preferred (SAP, oracle…)
This position will manage the regulatory process but will not be handling any submissions, just process support for regulatory.
Will be processing KPI’s and reporting out on KPI’s. Will work cross functionally with many others within company. Must have excellent and clear communication skills.

Role Summary:

The Operations Specialist, Regulatory Affairs, role will partner closely with Director, Regulatory Affairs Operations & Intelligence, to support regulatory intelligence activities that ensure compliance of new and currently marketed products, taking into consideration current and proposed changes in regulatory requirements and standards globally.
Providing support to administrative registration activities to facilitate timely regulatory submissions and market authorization/approvals.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Responsibilities:

Responsible to work collaboratively with local (US & Canada), International (EMEA, Eurasia, APAC & LatAM) Regulatory teams, and other cross-functional stakeholders to implement regulatory policies, processes & procedures, systems, and reporting mechanisms/tools in compliance with regulatory requirements ensuring alignment with overall business strategic goals/priorities.
Actively participate and provide input/guidance in new/product development (design control, essential requirements, harmonized international and global Standards, and related activities) with respect to global regulatory requirements as applicable.
Facilitate timely review/approval of document and product changes (e.g., ECO/DCOs) that affect in-country regions, especially those concerning significant changes and revisions to ensure ongoing compliance.
Responsible for synchronizing regional ‘in-country’ regulatory requirements with global/corporate processes, procedures, and systems in collaboration with US, EMEA regulatory and other stakeholders e.g., Quality, R & D, Marketing, Operations, PMS and Doc Control.
Proactively keep abreast of changes in global laws, regulations, standards/guidance and assess their impact and make recommendations to ensure compliance and provide regular reporting across the organization on key developments that impact customers or business directly.
Collaborate with Marketing, Market Access, Clinical, labelling, R&D and other departments, to develop compliant product, review/approve product labeling and advertising & promotional material for compliance based on regional in-country RA requirements.
Maintain regulatory records and files.
Performs other duties as required.

Requirements:

B.S./B.A. (4-year Degree) and/or an equivalent combination of education and experience/background in life sciences, technical (engineering) or related field.
RAPS (RAC) Certification is preferred.
2+ years of Medical Device Regulatory Affairs experience.
Working knowledge of International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF.) required.
Experience in prioritizing and exercising sound judgment in RA & QA matters is required.
Bachelor's Degree and 1 year experience in the medical device industry
Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
Strong written and verbal communication skills
Proficient project management skills.
PC skill e.g., word processing, spreadsheet, database, Internet search and utilization.
Flexible and able to work in a fast-paced environment.
English read/write fluency a MUST. A second global language is a plus.
Team player with excellent organizational and interpersonal skills.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records