closeX
New User
Forgot Password ?
Job Description
Job: Project Manager - Regulatory Affairs
Innovation, R&D, Marketing & Communications, Strategy role
Full Time Job
Posted on: January 27, 2020
Locations: USA (California)
Job Description:
(primary responsibilities,
reporting structure,
career path...)
This is a newly-created, full-time position. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific; regulatory and business issues to enable products that are developed; manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert

resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

Responsible for compliance with applicable Corporate and Divisional Policies and

procedures.

Core job responsibilities for this function may include:

• Develop new regulatory policies; processes and SOPs and train key personnel on them

• Evaluate regulatory risks of division policies; processes; procedures

• Provide regulatory input to product lifecycle planning

• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management

• Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes

• Assist in regulatory due diligence for potential and new acquisitions

• Utilize technical regulatory skills to propose strategies on complex issues

• Determine submission and approval requirements

• Identify emerging issues

• Monitor trade association positions for impact on company products

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

• Recruit; develop and mentor regulatory professionals

• Assess the acceptability of quality; preclinical and clinical documentation for

submission filing

• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions

• Compile; prepare; review and submit regulatory submission to authorities

• Monitor impact of changing regulations on submission strategies and update internal stakeholders

• Monitor applications under regulatory review

• Communicate application progress to internal stakeholders

• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

• Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies

• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

• Provide strategic input and technical guidance on regulatory requirements to

development teams

• Manage and execute preapproval compliance activities

• Oversee processes involved with maintaining annual licenses; registrations; listings and patent information

• Ensure compliance with product post marketing approval requirements

• Review and approve advertising and promotional items to ensure regulatory compliance

• Ensure external communications meet regulations

• Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events

• Actively contribute to the development and functioning of the crisis/issue management program

• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies

• Report adverse events to regulatory agencies and internal stakeholders

• Provide regulatory input for product recalls and recall communications

Supervisory / Management Responsibilities

Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. May also mentor other department members.

Position Accountability / Scope:

Individuals execute and manage technical and scientific regulatory activities. Must

function independently as a decision-maker on regulatory issues; and must assure that deadlines are met. Effectively communicate; prepare; and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.
Qualifications
Preferred/Required:
Job qualifications and experience, academic degrees, personal traits...
Minimum Education Required:

Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred.

A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Minimum Experience / Training Required:

2-5 years of experience in regulatory preferred but may consider quality assurance,

research and development/support, scientific affairs, operations, or related area.

4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals).

Preferred Experience, Education, etc.:
5-7 years of Regulatory medical device experience (IVD preferred)
2-3 years’ experience with 510(k) clearances (in-person FDA meetings preferred)
2-3 years’ experience with CE Technical Files competed, with Notified Body approvals
Experience with MDR (IVDR preferred)
Experience independently managing projects that led to product launches from Regulatory perspective
Experience with effective cross-functional team interaction, etc.

Related Services