About This Role
iRhythm is currently seeking an experienced Staff Regulatory Affairs Specialist. This can be a remote or local position and 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 Staff 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 and develop global product registration strategies, help guide project teams from preparation to submission and through successful dossier reviews with global regulatory agencies to gain and maintain international product registrations. You will independently organize regulatory information and apply advanced regulatory expertise to guide cross-functional partners through 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:
- Develop sound global, regional, and multi-country regulatory strategies for new and modified medical devices such as SaMD, wearable patches and/or OTC devices
- Provide regulatory intelligence to aid in market assessments and portfolio planning
- Prepare international and domestic submissions/registrations to established timelines and company objectives (e.g.,510(k), Q-submissions, Technical Documentations)
- Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams
- Collaborate with cross functional partners in driving and implementing new process to address non conformances or remediation efforts.
- 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
- Defining requlatory requirements on device labeling and review labeling content for compliance for global markets
- 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
- Monitor impact of changing global regulations on submission strategies & registrations
- Perform other quality and regulatory-related duties as assigned.
About you:
- >8 years of regulatory affairs experience with a Bachelor’s degree (B.A./B.S. required); >6 years experience with Master’s or other advanced degree in a related field
- Lead and/or author 510k or MDR submission experience required
- Software as a medical device (SaMD) experience highly preferred
- Wearable and OTC medical device experience preferred
- Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, 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 experience highly preferred
- Strong project management skills
- Exceptional problem-solving skills
- Exceptional organizational skills
- Exceptional communication (written and oral) skills
- Willingness to travel when required, up to 10%
What's In It For You
This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:
- emotional health support for you and your loved ones
- legal / financial / identity theft/ pet and child referral assistance
- paid parental leave, paid holidays, travel assistance for personal trips and PTO!
iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more!
FLSA Status: Exempt
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