Sr. Regulatory Affairs Specialist
About The Position
Cynosure is a market leader in medical aesthetics with over 25 years of experience developing, manufacturing, and marketing products for dermatologists, plastic surgeons, medical spas, and healthcare practitioners. The company has a comprehensive product portfolio spanning skin revitalization, body contouring, hair removal, and women's health. Cynosure is committed to innovation, global expansion, and fostering a culture where employees are valued and encouraged to lead, create, and add value. This role is responsible for handling complex regulatory submissions with minimal supervision, organizing regulatory information, tracking and controlling submissions, and reviewing and advising on labeling for compliance with regulatory filings. The specialist will also review product changes for their impact on worldwide regulatory filings and research regulatory issues to provide guidance to colleagues.
Requirements
- Bachelor’s degree required in Engineering or a scientific field.
- 5 to 8 years relevant experience within Quality / Clinical / Regulatory discipline.
- Excellent communication skills.
- Ability to manage multiple priorities.
- Requires creative, problem-solving ability and oral and written presentation skills.
- Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently.
- Good planning and organization skills are vital.
- Strong critical thinking and problem-solving skills.
- Effective verbal and written communication skills are essential.
- Knowledge of US and international medical device regulatory requirements.
- Experience with submitting 510(k)s is mandatory.
- International experience is required.
- Requires proficiency with standard software (Word, Excel, PowerPoint, etc.).
- The ability to meet deadlines and be detailed orientated is necessary.
Nice To Haves
- Experience with electromechanical and/or software devices is a plus.
- Strong understanding of design controls.
Responsibilities
- Completes submissions for countries that have complex requirements such as US FDA (510(k)s) Canada, China and/or EU with minimal supervision.
- Creates Regulatory plans for cross functional teams as input into design and development.
- Executes Regulatory plans domestically and internationally.
- Work interdepartmentally to satisfy international requirements during registration.
- Provide regulatory guidance to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
- 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 or partners.
- Review labeling and labels for compliance with regulatory requirements.
- Review changes to existing products and SOPs to define the requirements for regulatory submissions.
- Provide regulatory reviews of customer complaints and define the regulatory reportability.
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
- Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Embody and live our company Values.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
