Senior Regulatory Affairs Specialist
Location: Bedford, MA
The role of the Senior Regulatory Affairs Specialist is to execute on the global regulatory programs in accordance with current global regulations. The individual will coordinate the collection of information and documentation and compile into submissions, license renewals, periodic updates and registrations to regulatory agencies and partners worldwide. The individual will be responsible for the review of labeling, protocols, product development and manufacturing documents for compliance with regulatory requirements.
Strategic Focus Areas:
The Senior Regulatory Affairs Specialist will plan a key role as the executor of the corporate regulatory strategy. This individual will provide input into regulatory programs and ensure that the organization stays compliant to worldwide regulatory requirements.
- Collect and coordinate documentation to prepare regulatory documentation packages for submissions to regulatory agencies, i.e., 510(K), PMA, Technical Documentation, etc.
- Support product development projects and provide regulatory guidance from Design Control perspective
- Review and conduct regulatory assessment for the post-launch changes and file supplement, change notifications to the regulatory Agencies.
- Conduct regulatory review for various product and production documents
- Establish and maintain various Regulatory database or tracking system
- Conduct annual regulatory filings, i.e. annual report for PMA, NAND, IND and IDE.
- Maintain current knowledge of international regulation, guidance and standards applicable to Anika products
- Maintain regulatory files/database and chronologies in good order
- Review labeling for regulatory compliance
- Research for various regulatory topics, disseminate regulatory information to Production, QA/QC, and R&D departments and senior management
- Responsible for other duties and projects as assigned
Exercises adequate judgment within defined procedures. Works independently on problems of moderate to diverse scope. Normally receives minimum instructions on routine work, may require instruction on new and complex assignments.
Bachelor’s degree, preferably in life sciences or related field
Desired Experience, Knowledge, and Skills:
- 5+ years of regulatory affairs experience
- Demonstrated knowledge and working experience on Design Control
- Great knowledge on FDA regulations, EU MDR and MDD, International experience is a plus
- Work effectively with cross functions
- Excellent project management skills with the ability to multi-task
- Ability to work autonomously, effectively manage time and deliver results on time
- Excellent presentation skills, both written and in platform presentation format
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.