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Manager of Regulatory Affairs

Job Description

Our client is a leading medical device company and is currently seeking an accomplished Manager of Regulatory Affairs to join the team. Here is an overview of the role:

1) Research system options and current regulatory guidance and proposes best options and strategies
2) Work with regulatory and cross-functional team members to execute a project
3) Call and conduct team meetings
4) Collaborate with team members to ensure open communication
5) Ensure submissions and related documents meet local and global needs
6) Maintain global regulatory strategy and communicate changes to the strategy to regulatory and related groups
7) Be accountable for global regulatory submissions, authoring and management of information for timely and approvals
8) Provide regulatory support to new product development teams to ensure that all relevant regulatory requirements are incorporated as part of the development process
9) Manage the review and approval of all engineering changes
10) Oversee the maintenance of the appropriate regulatory restrictions on products in the data system, including restricting sale of products not yet cleared through a regulatory pathway
11) Designate, oversee and/or review all custom devices
12) Manage creation, review and approval of new product labels and instructions for use
13) Ensure the appropriate oversight and approval for all informational material released to the field
14) Liaise with regulatory authorities and participate in/lead regulatory meetings with agencies
15) Prioritize workload to ensure that business critical and compliance issues are met
16) Escalate critical issues to the respective managers in order to resolve issues proactively
17) Maintain regulatory procedures, track required timing on updates and propose new procedures or revisions to current procedures as needed
18) Work with teams globally to ensure alignment and agreement on procedures and implementation
19) Track timelines, deadlines and progress
20) Report out as required by product group teams and regulatory management
21) Manage direct reports in support of development of strategies, timelines and submissions
22) Perform related duties as required
More questions? Want to know the Salary range? Keep reading.

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TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety

Job Requirements

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people have recent experience in regulatory affairs management

If you believe you have the ability to excel in this role, this could be the right opportunity to work with a great company in the medical device industry.

Job Snapshot

Post Date 4/13/2014
Location Raleigh, NC
Employment Type Full-Time
Job Type Science, QA - Quality Control
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Biotechnology, Pharmaceutical, Medical Equipment
Required Travel Not Specified
Job ID USA-5762
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