Sr. Regulatory Affairs Specialist (Remote)

CIVCO’s success is built by passionate employees who help create innovative, life-enhancing solutions. We like to celebrate our successes and promote a positive, enjoyable work environment. If these are key values you are looking for, CIVCO is a perfect match. Challenge Yourself. Change Lives.

Summary

Responsible for leading business unit regulatory initiatives and providing regulatory support for new product development projects, new global registrations, creation of technical file documentation and compliance support.

This is a remote position based out of a home office.

Key Duties and Responsibilities (other duties may be assigned)

• Regulatory Administration
  • Reviews and approves change orders, deviations, risk management documentation, non-conforming material reports as the Regulatory designee. Ensures compliance and no impact to existing regulatory licenses.
  • May serve as the lead for international UDI compliance.
• Global Registrations
  • Compiles and submits regulatory documentation dossiers for new market registrations, significant change notifications, license renewals and annual registrations.
  • Supports completion of regulatory certificates as required.
  • Act as a lead and/or mentor for 510k submissions.
  • Performs gap analysis of new regulations and regulatory standards (primarily EU and MDSAP countries) and makes recommendations for QMS changes.
• Quality systems support
  • Leads compliance process improvement and standardization initiatives. Evaluates and recommends improvements with respect to compliance to FDA, MDD, MDR, MDSAP and other international regulatory requirements.
  • May be asked to support and/or lead front room and back-room activities for QMS audits.
  • Supports root cause and action plan develop/execution on CAPA activities as required.
  • Create and maintain regulatory processes and work instructions as needed including the recommendation and documentation of regulatory department best practices.
• Vigilance
  • Leads team in drafting health hazard evaluations as needed to support NCMR’s, complaints, and vigilance activities. Reviews MDR and vigilance reports for submissions as necessary.
• Product Development Support
  • Lead and/or mentor 510k documentation creation/submission for new product development.
  • Represents Regulatory at Design Reviews, device releases, and other activities requiring Regulatory approvals and acts as lead to determine regulatory strategy on new product designs.
• Technical File Creation/Maintenance
  • Updates TFA files in respect to declarations of conformance, master listings, medical device directive checklists, and assisting with clinical evaluation reporting document reviews.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Bachelor’s degree in a related field from a four-year college or university and 5 to 8 years related experience and/or training as a quality, biomedical, manufacturing, or regulatory professional; or equivalent combination of education and experience.

Knowledge, Skills, and Abilities

• Strong working knowledge of Quality System Regulations and ISO Standards with expertise (or specialization) in some areas.
• Demonstrated understanding and use of quality tools.
• Demonstrated interpersonal skills
• Thorough understanding of verification and validations for design, processes, equipment and components.
• Ability to lead research and requirements definition for gaining entry to foreign markets.
• Highly detail oriented

Travel

National and international travel may be required up to 10% (4-8 travel trips per year) of the time.

Pay & Benefits

CIVCO offers a complete benefits package including company-sponsored health plans and 401k plans with company matching starting day one, lifestyle and tuition reimbursements, paid leave, and the advantages of an environment that supports your development and recognizes your achievements. 

Compensation Range (annual): $88,000-$134,000 plus an annual performance-based incentive of 10%

The provided compensation range is used nationally. The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk.  The employee is required to travel by automobile and other means. Specific vision abilities required by this job include close vision. The employee must occasionally lift and/or move up to 50 pounds.

Work Environment

This is a field-based position requiring a home office. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)