Skip to Main Content
← Back to Jobs

Regulatory Affairs Leader

HireResources a Tailored Solutions Company (WO) Oceanside ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

AMAZING POSITION WITH A WORLD LEADER IN MEDICAL DEVICES

 

OUR CLIENT:

Very stable major company with an excellent career runway and benefits. This company is renowned for their top tier medical devices.

The right candidate will have a strong Regulatory Affairs background.  This is not a position for QA's.  

 

KEY RESPONSIBILITIES:

• Create and manage domestic and global product submissions (e.g. EU Technical Files, International Dossiers, 510ks), including CFGs, Certificates of Free Trade, and legalization of regulatory documentation

• Manage internal processes to meet FDA, EU, Health Canada, Notified Body, and other regulatory authority requirements

• Complete regulatory assessments for new products or product modifications and develop regulatory strategies for their respective product launches domestically and internationally

• Support and provide regulatory guidance on pre-production and design releases of new product development for domestic and international distribution

• Maintain current state and federal registrations (wholesale distribution)

• Review and approve labeling and promotional materials

• Manage regulatory compliance activities such as HHEs, adverse event reporting, and recall execution and reporting

• Monitor and communicate changes to regulations, legislation, guidance documents, and policy to determine the impact on the organization

• Oversee government inspection activities, including inspectional observations, as well as corrective action plans

• Train and develop direct reports to ensure successful TSM growth within the organization

 

PLEASE NOTE THIS IS NOT A REMOTE POSITION

 

WORK EXPERIENCE: 5+ YEARS

MUST HAVE DOSSIER EXPERIENCE

510K EXPERIENCE

FDA

MANAGEMENT/LEADERSHIP EXPERIENCE

 

PREFERRED EDUCATION:

Bachelor's degree (BA/BS) required

Master's degree or RAC certification desired

 

GENERAL SKILLS & COMPETENCIES:

• Attract, retain, motivate, coach, and develop team members for high performance

• Broad and wide range of professional and managerial skills with a full understanding of industry practices and company policies and procedures

• Use skills to lead teams to achieve company goals in creative and effective ways

• Excellent planning/ organizational skills and techniques

• Excellent analysis and problem-solving skills

• Excellent decision-making skills

• Excellent negotiating skills

• Excellent writing and communication skills

• Ability to lead virtual teams

• Communicate effectively with senior management and key stakeholders

• Ability to Influence, build relationships, navigate politics, and manage conflicts

• Understand, interpret, and act on financial information that contributes to business profitability

• Ability to plan and manage successful projects, manage risks, costs, time, and project teams

 

SPECIFIC KNOWLEDGE & SKILLS:

• Experience within the medical device and/or pharmaceutical industries

• Deep knowledge and understanding of regulations and guidelines governing medical device manufacturing and/or healthcare distribution

• General knowledge of surrounding areas including FDA, Canada, EU regulations; Quality System Regulations; MDSAP, and ISO certifications

• Strong understanding of manufacturing and/or distribution and auditing processes

 

 

Company Description
The cornerstone of HireResources success is in its commitment to ethical business practices and superb consumer service.
Our "Code of Ethics"​ is the foundation of this success.
Integrity - Work honestly, every day.
People - Develop and deliver diverse talent Customer
Focus - Anticipate priorities & exceed their expectations
Respect - Value all customers and collaborate with one another
Performance - Be accountable, manage risks and deliver a high level of quality.

HireResources a Tailored Solutions Company (WO)

Address

Oceanside, CA
USA

Website