International Regulatory Affairs Specialist I
Location: Bedford, MA, Remote
Under the general guidance, the International Regulatory Affairs Specialist I is responsible to collect data and documents, and other regulatory activities required for global product market approval, and post-approval requirements.
- Achieve and maintain state licensing registrations and is the primary liaison with 3rd party vendor; may interact with state agencies.
- Collaborate with cross functions to collect the data and information, assemble regulatory documentation packages to local commercial partners for international product registrations
- Organize regulatory information sources; establish and maintain regulatory database and system
- Archive regulatory records, i.e. international registration submissions, PMAs, 510(K)s, IDEs, NDAs, supplements and annual reports
- Under guidance, may review labeling and other product and production documents for compliance with regulations
- Conduct basic regulatory research to address specific topics and determine regulatory requirements for specific countries
- Responsible for other duties and projects as assigned
Normally receives general instructions on routine work, detailed instruction on new assignments.
Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Build productive internal/external working relationships.
- Bachelor’s degree, preferably in life sciences or related field
- Regulatory Affairs Certification preferred
Desired Experience, Knowledge, and Skills:
- Minimum of 3 years working experience as Regulatory Affairs professional, internship experience considered
- General understanding of regulations by FDA, EU and other regulatory agencies globally
- Ethics: Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
- Communication: able to deliver fluently in a clear and concise manner; effectively explain and relay information
- Dependability: Consistently meet or exceed expectations in completing assignments thoroughly and timely
- Teamwork & Cooperation: Demonstrate commitment to achieve team goals; engages others
- Attention to Detail/Quality: Task are performed with accuracy and against high quality standard
- Problem Solving: Use data, experience, and team input to generate solutions
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.