Regulatory Affairs Specialist 4

Job Description

Why Hologic?

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

The position has primary responsibility for compliance with US, EU and Canadian regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for medical devices and includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing US promotional materials, and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through the collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside their own area of expertise.

Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).

What to Expect:

• Directly support regulatory activities associated with warning letter remediation efforts including the preparation and compiling of documentation packages for regulatory submissions, audits, and inspections. Provides technical review of data or reports that will be incorporated to assure scientific rigor, accuracy, and clarity of presentation.
• Oversees regulatory submission strategy development and activities of major significance, which are highly difficult and complex in nature.
• Responsible for management and maintenance of regulatory databases and technical files.
• Significant contributor in internal and external audits and investigations. Will coordinate the collaboration of stakeholders and provide technical expertise.
• Responsible for reviewing materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
• Responsible for labeling and unique device identification requirements.
• Drives RA projects or cross functional project teams. Provides subject matter expertise and/or acts as project lead on design reviews and regulatory strategies for product approval.
• Consistently participates in the development or improvement of processes, procedures and standards that contribute to meeting internal SOP's, regulatory and industry regulations.
• Maintains current knowledge of existing and emerging regulations, standards and laws. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

What we Expect:

• Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
• Proficient with technology applications such as MS Office,
• Proficient in the creation of technical files and documentation. Strong knowledge of document management systems.
• Thorough Knowledge of ISO 13485, ISO 9001, FDA and foreign regulatory requirements
• Excellent data and statistical analysis skills and ability to use data for problem solving and to make informed recommendations.
• High degree of attention to detail
• Regulatory Affairs Certification (RAC) is beneficial.
• Project Management Experience is beneficial.

Education & Experience:

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Master's Degree
• Preferred Minimum Non-Technical Degree: 8+ Years
• Preferred Minimum Technical/Advanced Degree: 6+ Years with Master's Degree, 3+ Years with PhD
  • Experience working in regulated medical device industry
  • Experience with 483, warning letter or consent decree remediation efforts preferred

Must follow all applicable FDA regulations and ISO requirements.

The annualized base salary range for this role is $115,600 to $150,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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