Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Regulatory Affairs Specialist is an intermediate level role responsible for implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Responsibilities include analysis and review of data, resolution of regulatory issues of moderate scope, maintenance/update of existing technical files and ensuring that new products are compliant to new requirements.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.
Provide regulatory input to cross-functional teams. \
Works mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions.
Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions.
Author draft submissions under supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.
Under supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements.
Begin to interact with Regulatory Body personnel under direct supervision.
Actively assist with upcoming audits and certification reviews with all Company designated Notified Bodies. Support communication with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews.
Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.
Review promotional and advertising material for adherence to approved product claims and regulatory compliance.
Work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and international regulations.
Coordinate rollouts of product changes with corporate and international regulatory teams.
Coordinate Unique Device Identification system requirements and other labeling compliance of new products introduced into the market.
Work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971 under supervision.
Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. Works under moderate supervision.
Review labeling that requires regulatory review and approval to ensure compliance with government regulations.
Problem solving: Apply company policies and procedures to resolve a variety of issues of moderate complexity; Provide solutions to a variety of problems of moderate scope and complexity.
Participate in continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned. Contribute to the authoring of SOPs.
Perform other duties as assigned.
Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor’s degree in science, Engineering, Regulatory Affairs, or other technically related field.
Minimum of 2 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 1 year in Regulatory Affairs and the other year can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met:
RA Certification (RAC) can count towards 1 year of specific RA experience
Master's degree can count towards 2 years of relevant (non-RA) experience
Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.
Experience in working effectively with cross-functional teams (e.g., manufacturing sites, new product development teams, marketing teams, quality teams).
Experience with medical device, biologic or implantable products is preferred, but not required.
Awareness of business strategies and tactics, including an understanding of regulatory impact.
Must have proven ability to prepare and submit documents to regulatory agencies, with supervision.
Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
Can communicate existing facts in an organized and clear manner to cross-functional teams.
Must be detail oriented, well-organized, and able to work both independently and in teams.
Must possess and demonstrate an understanding of FDA requirements and quality system requirements.
Must have strong writing, project management and communication skills.
Demonstrated skills in contributing to multiple projects simultaneously.
Established skill in objective thinking.
Brings proposals for solutions to identified issues.
Develops plans to meet pre-defined Regulatory goals.
Responsible for tasks and intermediate submission components, based on templates.
Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
Willingness to take ownership and accept responsibility for actions and decisions.
Ability to communicate effectively in both informal and formal settings.
Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job.
Salary Pay Range:
$71,300.00 - $97,750.00 USD SalaryOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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