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Manager/Sr. Manager Regulatory Affairs

Manager/Sr. Manager Regulatory Affairs Manager/Sr. Manager Regulatory Affairs SU

2020
2019-07-19
QualStaff Resources
Position: Sr. Manager Salary: Unspecified Type: Full Time Location: San Diego, CA
Manager/Sr. Manager Regulatory Affairs
SUMMARY:
This role is responsible for planning and preparing Class II and Class III medical device regulatory submission documents
and will provide support for global regulatory filings, including EU, China and Japan. The Manager will lead and participate
in global regulatory teams, interpret regulations and provide regulatory guidance. They will support management with
regulatory program planning and implementation of departmental strategies and policies.
ESSENTIAL FUNCTIONS:
Submissions, development and regulatory lifecycle maintenance.
Plans and prepares regulatory documents for US and ROW product approvals with minimum supervision.
Prepares clear and accurate internal and external administrative and scientific documents needed for regulatory
submissions, under minimal supervision.
Prepares comprehensive and complete technical documents and on time.
Manages post-approval projects
Approves manufacturing process changes as appropriate.
Reviews labeling and packaging components to ensure accuracy and compliance with government regulations.
Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes
with operations, commercial, clinical affairs and marketing.
Participates in global teams and provides regulatory strategy and guidance to global product development teams.
Under supervision with the Director develops global regulatory filing strategy.
Makes recommendations to shape the global strategy in line with regional/commercial objectives
Critically reviews reports, validations, etc. for scientific merit and regulatory appropriateness.
Works collaboratively with cross-functional teams to resolve complex project issues.
Maintains professional relationships within the regulatory groups and with functional areas outside regulatory.
In-depth knowledge of US medical device US and EU regulations for Class II and Class III medical devices.
Experience creating, reviewing, updating CERs.
Ability to meet deadlines; take initiatives and make decisions within department/company guidelines.
EDUCATION/EXPERIENCE REQUIRED:
Education equivalent to a BS degree in a scientific field, plus 5 years’ experience in regulatory affairs; or
Education equivalent to a MS degree in a scientific field, plus 3 years’ experience in regulatory affairs;
Class III medical device experience required
REQUIRED SKILLS:
Demonstrate effective cross functional skills including ability to impact industry/agency organization decisions.
Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall
business objectives into the goals/vision/values of department and communicate these effectively and demonstrate
optimism and energy in the face of change.
Ability to work both independently with minimal direction to attain group goals and key project milestones.
Ability to work closely with those within the Regulatory/Quality departments.
Demonstrate strong skills to organize, prioritize, and execute.
REQUIRED COMPETENCIES:
Performance Orientation – Is driven by personal performance; achieves all objectives detailed in Department goals and
comfortable with quantifiable assessments.
Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
Competitive – Dedicated to a competitive spirit that supports the goal to be the premier Medical Device company in the
industry.
Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain
composure and focus in situations of ambiguity and uncertainty.
Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to
finish especially in the face of resistance or setbacks.
Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
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