Regulatory Affairs Manager

Chemence•Alpharetta, GA

1d•Onsite

About The Position

Under general supervision, this role is responsible for assisting in the development and maintenance of international regulatory submissions, systems, and processes to support the identification, preparation, organization, and classification of all documents utilized for obtaining global medical device regulatory clearances as required to import, market, distribute, and maintain products in international markets. This role will also contribute by monitoring and analyzing regulatory trends and positions of industry within the consumer and medical divisions. This role will be responsible for assisting in the execution of defined regulatory strategies. This individual is responsible for liaising with other departments, external consultants, and the regulatory team to ensure registrations, GSPRs, conformity assessments, and other relevant documentation are accurate and up-to-date. This role will also sit on assigned project teams to provide regulatory guidance and disseminate regulatory information, as needed.

Requirements

Minimum BA/BS degree in scientific or legal discipline
10-15 years’ experience in Regulatory
Understanding of the European Medical Device Regulations (MDR) or ability to quickly learn requirements
Understanding of the Medical Device Single Audit Program (MDSAP) or ability to quickly learn requirements
Experience with chemical or product registration/notification in different applicable areas, preferably for Medical, Electronics and/or Cosmetics applications.
Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels.
Exhibits a high degree of integrity, initiative and motivation.
Strong ethics and regulatory compliance awareness.
Attention to detail and ability to manage multiple tasks.
Capacity to work independently, with excellent time management and judgment in task prioritization.
Able to interact with multiple individuals in a positive, constructive manner and under a variety of circumstances.
Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders.
Capability to understand technical information/science as it applies to products, and the ability to translate into a business context.
Excellent English verbal and written communication skills.
Computer skills with proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat.

Nice To Haves

Audit experience preferable. (ISO, EU MDR, MDSAP)
Bilingual (Spanish) a plus.

Responsibilities

Ensures compliance with regulatory requirements and internal procedures.
Provides guidance on regulatory requirements and strategies to project teams.
Prepare and submit product registrations and submissions (510 (k), PMA) to FDA and other regulatory bodies.
Assists in regulatory matters involving the US FDA and other government agencies, as directed.
Communicate Regulatory requirements throughout the organization as appropriate.
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners according to the defined regulatory submission strategy.
Timely compile materials for license renewals, updates, and registrations.
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies and partners.
Maintain current knowledge of FDA and international regulations, guidance, and standards applicable to company products.
Oversee the fulfillment of general safety and performance requirements, conformity assessments, compliance with labeling and distributor/importer requirements.
Lead regulatory intelligence efforts and participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC and R&D department and senior management as required.
May perform other duties as required.