Regulatory Affairs Manager

3 weeks ago

Lake Forest, United States eVent Medical, Ltd Full time

GENERAL  SUMMARY

The Regulatory Manager of eVent Medical has the prime responsibility for obtaining and maintaining product approvals and quality system certifications. The Regulatory Manager Key tasks and responsibilities are outlined below under appropriate headings.

1.      Essential Functions & Responsibilities (Other Functions May Be Assigned)

·      Ensure that the necessary product approvals (i.e. CE marking, 510(k)’s, Shonin etc.) are in place for all of eVent Medical products, based on planned markets.

·      Maintain the compliance status of the company with respect to quality system certifications to ISO 13485:, Canadian Requirements and Medical Device Directive Annex II EU MDR 2017/745.

·      Develop processes to ensure quality system compliance with the FDA Quality System Regulation (21 CFR Part 820, Part 803, Part 11).

·      Provide regulatory information and assistance for the Design, service and other technical functions in the company.

·      Liaise with Notified Bodies and/or Competent Authorities/FDA regarding regulatory and vigilance issues.

2.      Quality

·      Maintains MasterControl as part of regulatory information and changes.

·      Maintains Quality System documentation and regulatory files.

·      Ensure that the requirements relating to Management Responsibility are met, in particular, Management Review.

·      Develop and approve the company Quality Policy in conjunction with the Executive Management

·      Participate in decisions relating to Medical Device Vigilance, MDR’s, product recalls and issuance of Advisory Notices, if required.

·      Ensure that the company and its employees adhere to the requirements of the EU MDD 93/42/EEC, ISO 13485 and the FDA QSR EU MDR 2017/745.

·      Act as Training Coordinator for eVent employees.

3.      Housekeeping

·      Require and encourage employees to maintain their places of work in a clean and tidy state.

4.      Training

Mandatory

·      New Employee (when applicable)

·      All Employee

                     Job Specific

Regulatory Manager

Optional

·      Auditor

·      CAPA

·      Change Control User

·      Export Compliance

·      NCMR

·      Service User

·      Supervisor-Training

Additional

·      Participate in all relevant training and assessment activities. 

·      Participate in SOP training necessary for the performance of the Regulatory Manager function.

·      Attend training courses (internal and external) and seminars which are required for the effective performance of the Regulatory Manager job.

·      Ensure that all training and assessment is recorded and signed for on your Individual Training Record.

5.      Safety

·      Adhere to all safety policies, procedures and regulations issued by eVent Medical.

·      Ensure that work is carried out in a safe manner and relevant company or environmental legislation is adhered to.

·      Notify the appropriate authorities in accordance with relevant national regulations, of any breach of policy, procedure, regulation or potential hazard which could have a serious impact on safety or result in serious personal injury to an individual.

DESIGNATED AUTHORITY

·   Sign Declarations of Conformity per the requirements of the EU MDD 93/42/EEC, EU MDR 2017/745

·      Sign Medical Device Vigilance/MDR reports for notification to Competent Authorities/FDA.

·      Approve and sign Recall and other Advisory Notices.

·      Participate in Management Review meetings

·      Review/approval of change orders

·      Conduct device release activities

·      Participate in NCMR reviews

·      Review/approval of CAPA’s

·      Review/approval of Temporary Deviations

·      Conduct complaint and investigation decisions

·      Review/approval of validation activities

·      Communicate with regulatory agencies on behalf of the company in relation to quality or regulatory matters.


QUALIFICATIONS

EDUCATION/EXPERIENCE REQUIREMENTS

·     Bachelor’s degree. 

·     Requires a minimum of ten (10) years in quality assurance/regulatory affairs experience with emphasis in a medical device industry.

·     Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485, and the EU Medical Device Directive required.

·     Hands on experience with product documentation and the preparation of 510(k)s, and international dossiers. 

·     Experience with devices containing both hardware and software components.

·     Experience with 21 CFR Part 11 Electronic Systems

OTHER QUALIFICATIONS

·     Excellent communication, interpersonal, time management, and leadership skills.

·     Experience interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.

·     Proficiency in Microsoft Office Suite.

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