Senior Manager of Compliance overseeing compliance operations related to insurance regulations at Tokio Marine HCC. Leading a team to ensure adherence to regulatory standards and internal guidelines.
About the role
- Senior Regulatory Affairs Specialist in BD Life Sciences managing regulatory submissions for medical devices. Collaborating with cross-functional teams to ensure compliance and product approvals.
Responsibilities
- Manage the regulatory process by interacting directly with country RA partners and government agencies;
- Provide updates on status of applications submitted to appropriate internal stakeholders;
- Coordinate meetings between relevant departments when necessary;
- Oversee submission package preparation including compilation of documentation required under applicable law or regulation;
- Review draft documents prepared by others prior to submission;
- Prepare correspondence regarding outcomes of submissions;
- Respond promptly to queries received during evaluation period;
- Liaise effectively between internal departments & external authorities throughout lifecycle of application until final decision has been made;
- Participate actively in negotiations where required;
- Contribute meaningfully towards resolution of any issues raised by authorities during evaluation phase;
- Collaborate closely with internal functions such as Marketing, Sales, Technical Support etc., to understand customer needs better;
- Identify potential areas where improvements could be made to enhance overall performance of existing products;
- Monitor changes in legislation relating to medical device industry;
- Conduct regular audits to ensure compliance with relevant regulations governing medical devices;
- Work collaboratively with internal stakeholders such as R&D, Quality Control, Manufacturing etc. to gather information pertaining to safety and effectiveness of products being developed.
Requirements
- Minimum 5 years’ experience working within regulatory affairs environment preferably focused on medical devices industry.
- Experience MUST be within a REGULATED Industry (examples; Medical Device, Aerospace, Automotive, Pharmaceutical)
- Strong analytical skills coupled with ability to think critically & solve problems independently.
- Excellent interpersonal skills with proven track record of building effective relationships internally & externally.
- Ability to communicate clearly & concisely both verbally & written form.
- Proven ability to manage multiple projects simultaneously while meeting tight deadlines.
- Proficiency in Microsoft Office Suite required (Word, Excel, PowerPoint).
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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