About This Role:About this role:iRhythm's Regulatory Affairs team is looking for a strong candidate to fill the role of
Senior Regulatory Affairs Specialist with global regulatory expertise. This position provides an opportunity to be at the forefront of medical wearable and artificial intelligence technologies that are making a difference with patient outcomes and better healthcare.
As a remote
Senior Regulatory Affairs Specialist with a fast growing, AI software and wearable hardware medical device company, you will be responsible for working with cross functional teams to assess market requirements, develop global product registration strategies, help guide project teams from preparation to submission and through successful dossier reviews with various regulatory agencies to gain and maintain product registrations. You will independently organize regulatory information and apply regulatory expertise to guide cross-functional partners by strategic and creative thinking.
Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!
Specific job responsibilities include:- Develops sound global, regional, and multi-country regulatory strategies for new and modified medical devices
- Prepare international and domestic filings/registrations to established timelines and company objectives
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
- Interact with regulatory authorities during the development and review process to ensure submission approval
- Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams
- Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance
- Review and approve product design changes to maintain regulatory compliance for significant changes
- Author or revise SOPs to improve regulatory compliance of the Quality System
- Review and approve advertising and promotional items to drive global labeling alignment as well as market-specific regulatory compliance
- Support product recalls and communications for internationally commercialize products
- Monitor impact of changing global regulations on submission strategies & registrations
- Perform other quality and regulatory-related duties as assigned.
About you:Required Qualifications- Bachelor's degree (B.A./B.S. required);
- 3 years of Regulatory Affairs experience in the medical device industry
- Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, UKCA, ASIA PAC, LATAM, etc. highly preferred
- Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA and other international regulations/directives/standards highly preferred
- Product development or sustaining/life cycle management experience required
- Exceptional communication (written and oral) skills
- Exceptional problem-solving skills
- Exceptional organizational skills
- Willingness to travel when required, up to 10%
Preferred Qualifications- Master's or other advanced degree in a related field preferred
- SaMD/MDSW, wearable, and OTC medical device experience highly preferred
- Project management skills
What's in it for you:This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!
iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!
FLSA Status: Exempt
Location:Remote - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range$99,000.00 - $129,000.00
