Regulatory Affairs Manager

Overview

Job summary:

Manages systems and tasks to ensure that the company's products consistently meet or exceed
established compliance and quality standards. Ensures that processes and work practices are
compliant to local, state, federal and international regulations which pertain to medical device
and medical device manufacturing requirements; worker health and safety, and environmental
protection.

Provide regulatory input to product development, market strategy, and business
planning. Support/execute planned facility and product development RA strategies.
Responsibilities include support QA/RA related operational activities within the Quality System
that may include processes such as Complaints/CAPA, Audits, Deviations and Process/Product
Validations and Design Control deliverables.

Job duties:

• Work closely with Product development teams to ensure regulatory
  requirements are met on all projects with direct responsibility for
  biological/clinical deliverables such as biocompatibility, cleaning/sterilization,
  clinical evaluations, and regulatory licenses/submissions/listings/certifications.

• Prepare Quality Assurance/Regulatory reports and present status in review
  meetings.

• Prepare reports and documents necessary for Regulatory Agency
  submissions or in support of customer QARA needs (DHF, Licenses/Listings,
  Certifications

• Perform research to determine Regulatory requirements of new markets &
  product requirements.

• Communicate and advise customers on Regulatory issues.
  Host internal, agency and customer audits.

• Respond to safety inspection findings.

• Provide safety and quality system training to employees.

• Create/Maintain product and facility licenses, listings, technical files and
  submissions.

• Support/fulfill requirements related to CAFDB, USFDA, EU MDD, Health Can,
  OSHA, DTSC, OC Health, and other regulating agencies.

• Maintain current procedures.

• Prepare 510K and CE Marking submission documents and maintain records.

• Prepare a variety of written correspondence and documents.

• Perform other duties as assigned.

Skills and qualifications:

Knowledge and complete understanding of 21 CFR Quality System Regulations/cGMPs and
ISO 13485 Quality System Standard. Must be proficient in EU medical device regulations. oUS
a plus.

Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills.
Proficiency in Access and ERP systems a plus. Critical thinking, facilitation, negotiation skills
and collaboration abilities essential.

• Ability to work with mathematical concepts such as probability and statistical inference.

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical
  situations.

• Ability to research, write and support regulatory strategies and supporting
  documentation/reports.

• Ability to analyze trends and draw logical conclusions.

Accountabilities:

• Manage and monitor the Regulatory and Safety issues and advise
  management on a timely
  basis.

• Develop new ideas and strategies to improve procedures or policies.

• Ascertain integrity/compliance of procedures.

• Ensure that work is being performed in accordance with documented
  procedures.

• Seek to improve and make changes in procedures to document "best
  practices".

• Keep up with all regulations and stay informed of organizational changes.

• Remain well prepared for audits by external agencies/organizations
  (including, but not limited to FDA, ISO, EPA, OSHA).

• Sustain safe work environment.

Education and experience:

• Bachelor of Science

• Must have experience in Quality Assurance and regulatory affairs

• Three or more years of experience in Quality and manufacturing

• Must have experience working with ISO Quality System Standard and Quality System Regulations

• Must have background working in medical device or IVD environment

• Must have experience in industrial hygiene/safety, government regulations, EC Directives, ISO, operational auditing

• Experience in work flow analysis, technical writing, and manufacturing operations preferred

Interpersonal and communications skills:

Position requires regular contact both inside and outside the company at all organizational
levels in order to carry out company business, policies, procedures, and regulations. Involves
considerable tact, discretion, and persuasion in order to obtain willing action and consent.

Regular contacts include, but are not limited to, the company President, QARA, Production
Management and Engineering. Contact with employees, customers, vendors and regulatory
agencies/registrars is frequent.

Reasoning ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions

• Ability to interpret an extensive amount of technical instructions in mathematical or diagram form and
  deal with several abstract and concrete variables.

Language skills:

• Must possess ability to read, write, speak, and comprehend the English language.

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical
  procedures, standards, or regulations

• Ability to write reports, business correspondence, and procedures

• Ability to effectively present information and respond to questions from groups of managers, customers, or the general public.

Supervision received:

Supervised by Director of QA/RA.

Supervision exercised:

Specialist

Mental, physical and visual demands:

Position entails some travel. Ability to work under pressure of deadlines is necessary

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For immediate consideration, please send us your most up to date resume.