Senior Regulatory Affairs Specialist at Green Key Lawrence, MA

Senior Regulatory Affairs Specialist – Green Key, Lawrence, MA

Job Description

The Senior Regulatory Affairs Specialist will help reach US and international regulatory clearance and approval goals. Working closely with fast-paced, exceptional cross‑functional teams, supporting them through product development stages and post‑market activities, this individual will focus on supporting the growth plan for the business by supporting capacity initiatives, supplier initiatives, and long‑term development projects.

Responsibilities

• Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and lifecycle management
• Provide guidance to project team members regarding regulatory compliance issues
• Conduct regulatory evaluation of changes to Patient Monitoring devices and accessories in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters‑To‑File)
• Identify regulatory process improvements and work to improve and implement robust processes
• Support preparation of materials, reports and follow‑up with Regulatory Agencies (i.e. Q‑Submissions, materials for Agency meetings, etc)
• Prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
• Support quality system and technical file/design dossier audits
• Provide regulatory guidance to junior members of the RA team and Cross Functional Team (CFT) members, specific to regulations and submission requirements that impact Patient Monitoring device registrations and approvals worldwide

Additional Responsibilities

Develops and helps drive regulatory strategies, timelines and commitments by driving:

• Path(s) to regulatory approval
• Helping to resolve risks and potential risks in the RA plan by collaborating, to the extent possible, with regional regulatory authorities and relevant regulatory agencies worldwide
• Exhibiting candor in communicating new risks or the status or existing risks with the impacted CFT, as well as management

Responsible for driving the procurement and assembly and packaging of the required deliverables for the submission of product registration and approval information.

Responsible for providing and helping to drive product support in preparing US and non‑US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by reviewing and approving related documentation as appropriate, which may be used as part of these submissions.

Providing and driving support for domestic (federal, state, and local) and International products registrations, by researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization).

Provide and driving import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.

Participates in and driving support for annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.

Maintain knowledge and application skills of regulations, standards and codes within job scope.

Performs other duties as needed and assigned.

Qualifications

• BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.
• 6-8 years of Regulatory experience in medical device industry is required.
• Minimum of 3 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.
• Regulatory Affairs Certification (RAC) a plus
• Knowledge of U.S. and International regulatory requirements for medical devices
• Proven record of supporting project teams
• Good Microsoft application skills
• Excellent written and oral communication skills
• In-depth knowledge of current ISO 9001, ISO 13485, CMDR SOR/98‑282, MDD 93/42/EEC, J‑GMP and 21 CFR Part 820

Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.