ResponsibilitiesThe Senior Regulatory Affairs Specialist will assist, lead and author documentation to support high-quality regulatory submissions. They will work closely with engineers, quality assurance, clinical and other technical experts to develop strategies to ensure compliance to regulations and to assist in responding to questions from regulatory authorities.
Key Responsibilities- Prepare and manage global regulatory submissions (EU MDR, FDA IDE/PMA, LATAM, APAC).
- Advise on regulatory strategies for development and marketed products.
- Lead process improvement initiatives to increase regulatory efficiency.
- Ensure ongoing compliance with QSR, ISO, and MDSAP requirements.
- Act as a regulatory representative on large projects/programs to provide regulatory strategy and planning in line with Product Development Procedure and Quality System requirements
- Ability to communicate regulatory requirements and impact of regulations to project teams
- Assist with development of global regulatory strategies for new and changing products
- Direct interaction with regulatory agencies
- Prepares and submits PMA's, PMA-A/S's, IDE's, Technical Files, Change Notifications
- Identifies and develops best practices within the Regulatory Affairs Department
- Supports internal and external audits
- Provides guidance and advice to other regulatory team members
- Supports regulatory compliance activities within business and corporation
- Keeps abreast of new and changing regulatory and quality system requirements
QualificationsRequired Qualifications- Strong experience with PMA authorship and submissions required
- Bachelor's degree in Science, Pharmacology, or related field.
- 5 + years of regulatory experience in medical device or pharma.
- Proven success with Class III device submissions and CE Marking.
- Experience with Class III Medical Devices.
- Experience with a variety of submission types including: IDE, PMA, Design Dossier/Change Notifications, Shonin Applications
- Fluent in English
Preferred Qualifications:
- Leadership or mentorship experience in regulatory affairs.
- Global regulatory knowledge across multiple regions.
- Experience with coronary/peripheral products [preferred]
- Experience with combination products [preferred]
Key Competencies- Strong written, organizational, verbal and project management skills
- Ability to work effectively in cross functional teams
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight
- Enjoy collaborating with others and creating alignment with team members
- Strong technical skills, critical thinking, and sound decision making.
Pay / CompensationThe expected pre-tax pay rate for this position is $89,000 - $119,000 annually. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
