Regulatory Affairs Specialist

Description

Position Summary :

An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through global regulatory approval processes.

Key responsibilities include capturing and communicating worldwide regulatory requirements for product modifications and preparing and submitting change notifications and technical documentation to local RA contacts. The position involves coordination with internal stakeholders, and direct communication with local regulatory contacts worldwide as needed.

Primary Duties

1. Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.

2. Perform assessment of change requests with minimal oversight.

3. Participate in the preparation of regulatory submissions (US, EU, Global) and additional information or responses as requested by regulatory agencies.

4. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

5. Perform interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.

6. Write or update standard operating procedures and work instructions.

7. Begin to advise project teams on subjects such as registration requirements, compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager.

8. Participate in the training of more junior regulatory personnel, as applicable.

9. Complete tasks with relatively little oversight.

10. Lead meetings and guide discussions regarding regulatory topics.

11. Lead projects with some guidance from senior regulatory employees / managers

12. Ensures accurate population of databases for tracking global product registrations.

13. Perform all work in compliance with company quality procedures and standards

14. Performs all other duties as assigned

Qualifications

Education :

Bachelor degree required

Experience :

1. 2+ years of experience in regulatory affairs

Knowledge, Skills, and Abilities

Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.

Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.

Planning objectives and strategies to achieve them within a set timeline

Informing others by sharing clear, timely information to ensure alignment

Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https : / / careers.biomerieux.com / or contact us at [emailprotected] .

BioMerieux Inc. and its affiliates are Equal Opportunity / Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected] , or by dialing 711 for access to Telecommunications Relay Services (TRS).