Job Title: Sr. Regulatory Affairs Specialist
Reports To: Director or VP RA/QA
FLSA Status: Exempt
Responsible for supporting regulatory activities including country registrations, maintaining technical files, and ensuring compliance to applicable regulations.
Primary Job Function:
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure regulatory compliance. The individual will provide regulatory support for product specific activities related to product registration in the United States and other countries worldwide. The individual may assist in identifying data needed, compiling data, organizing and preparing regulatory documents for registration. You may develop and prepare U.S. 510(k) submissions for Class II products, as well as (Technical files and dossiers) in support of market clearance for medical devices, as well as periodic reports and foreign regulatory submissions. Assist with development and maintenance of compliance systems including providing support of QA efforts in the development and maintenance of complaint processing and MDR / Vigilance reporting. Assist with development, review and approval of device labeling.
Essential Duties and Responsibilities:
- Develop regulatory strategy for registration activities
- Provide regulatory input to product lifecycle planning
- Determine and communicate submission and approval requirements
- Support country registrations in EU: Maintain current approvals, obtain approval in targeted countries
- Establish and maintain technical files for CE Marking
- Support country registrations in Asia/China: Provide appropriate requested documentation from Broncus China
- Support labeling activities (including IFU). Assist with label development and review for compliance
- Participate in risk management reviews and assessment of complaints
- Review plans, FMEAs, verification and validation protocols and reports
- Prepare and submit annual reports, as required by international regulations
- Maintain regulatory SOPs and review
- Review and approve Document Change Notifications; review for regulatory compliance and for impact on submissions
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Compile, prepare, review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies
- Monitor applications under regulatory review
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Maintain annual licenses, registrations, listings and patent information
- Assist compliance with product postmarketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance
- Submit and review change controls to determine the level of change and consequent submission requirements
- Analyze the input of cumulative product changes to current product submissions
- Contribute to the development and functioning of the crisis/ issue management program
- Review complaints for reportability decisions of malfunctions or product-associated events
- Provide regulatory input for product recalls and recall communications
- Support regulatory activities a needed/directed by Department Management (i.e. submissions, registrations, etc.)
The individual will help develop regulatory strategy for regulatory submissions in new markets.
Minimum Education and/or Experience:
- Bachelor’s degree in a scientific discipline required. Course program(s) or advanced training in Regulatory Affairs preferred.
- Minimum 7 years experience in the medical device industry with 5 years in regulatory affairs role in a small medical device company.
Licenses/Certifications: RAC Certification preferred
Special Requirements/Physical Demands/Working Conditions:
- Occasional domestic travel.
- Must have excellent verbal and interpersonal skills.
- Ability to work successfully with a variety of internal and external sources
- Ability to contribute and collaborate in a creative, fast-paced and team-oriented environment.
Administrative and Technical Skills:
- Previous FDA and OUS submission experience.
- Ability to manage multiple priorities in a high pressure environment.
- Working knowledge of current revisions of:
- EN ISO 13485: Medical Devices – Quality Management System
- Title 21 CFR Part 820: FDA Quality System Regulation
- MDD 93/42/EEC: Medical Devices Directive, as amended by Directive 2007/47/EC (5 September 2007)
- MDR 2017/745: Medical Devices Regulations (EU)
- EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
- Medical Device Regulations (Canada), SOR/98-282 (CMDR)
- Australia Therapeutic Goods (Medical Devices) Regulations 2002
- Australian Regulatory Guidelines for Medical Devices (ARGMD) 2011
- Applicable regulatory standards
- Other country regulations, as applicable
- Experience using Microsoft Office programs (or equivalent): Word, Excel, PowerPoint, Publisher is required.
Reasoning Ability and/or Critical Thinking:
- Excellent problem-solving skills.
- Ability to create and execute effective plans to address issues/goals.