Director of Regulatory Affairs
EnergyHub
Senior Regulatory Affairs Specialist
Medtronic
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $92,000 - $138,000 per year
Job Level
Senior
About the role
- Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations
- Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims
- Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data
- Advise on regulatory requirements and best practices for product advertising and promotion in EMEA
- Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contributing to updating processes
- Coordinate with regulatory specialist teammates on submissions and required documentation related to indications for use and regulator interactive review
- Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion
- Lead and support cross-regional review activities across Europe, Middle East, Africa, UK and Ireland
- Participate in occasional onsite meetings in North America (approximately twice per year)
Requirements
- Bachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review
- OR Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review
- Advanced degree (Master’s or equivalent) (nice to have)
- Experience with diabetes-related products or devices (nice to have)
- 4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
- Proficient understanding of EU MDR, FDA requirements
- Knowledge of Medical Device Quality Systems
- Experience working with international, cross-functional, and core-teams
- Product launch experience
- Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment
- Experience with Agile, Veeva PromoMats
- Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred)
- Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards
- Ability to interpret clinical data and publications in the context of promotional claims
- Exceptional attention to detail and strong communication skills
- Experience collaborating in cross-functional and international teams
- Strong oral and written communication skills
- Effective interpersonal skills
- Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint
Benefits
- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans (Medtronic Incentive Plan)
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsmedical device submissionsadvertising reviewEU MDRFDA requirementsMedical Device Quality Systemsproduct launchclinical data interpretationAgileVeeva PromoMats
Soft skills
attention to detailcommunication skillsinterpersonal skillscollaborationcross-functional teamworkleadershipguidancetrainingorganizational skillsproactive communication
