Compliance Officer at Scania managing the implementation of compliance systems and fostering a culture of integrity. Providing advisory support and promoting compliance within the organization.
About the role
- Senior Regulatory Affairs Specialist supporting research and development of medical devices at Medtronic. Ensures regulatory compliance for product submissions and market introductions.
Responsibilities
- Support Research and Development programs with pre-market regulatory strategy development
- Author and prepare regulatory submissions for new products
- Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements
- Find, interpret and apply regulations and guidance appropriately
- Provide regulatory support for currently marketed products as necessary
- Prepare submissions and reports for regulatory agencies as required
- Participate in project team meetings to plan strategies
- Provide mentorship, training and support to junior members
Requirements
- Bachelor’s degree in a technical discipline
- Minimum 4 years of medical device regulatory experience
- Experience working in regulated environment
- Master of Science Degree (Nice To Have)
- In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485
- Direct Regulatory Affairs experience supporting programs throughout software development life cycle.
- Direct experience authoring regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU
- Direct experience supporting successful software device development and associated regulatory filings
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Ability to support multiple projects and meet project deadlines
Benefits
- 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
- Incentive plans
- 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
- Capital Accumulation Plan (available to Vice Presidents and above)
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