Envista

Envista

Regulatory Affairs Specialist

United States of America, California, Brea · Mid

Sponsorship not specified$86k-$105kDetected 7 days ago
ComplianceRecruitingHRFDA RegulatoryMedical DevicesLeadershipProblem SolvingCritical ThinkingOrganizational SkillsMicrosoft OfficeRegulatory Affairs

About the role

  • SKILLS/ABILITIES: - Be respectful of peers.
  • Open-minded and willing to take an educated risk, fail fast and try again. - Ability to challenge the status quo and seek opportunities to set new standards. - Ability to take accountability of his/her work, good or bad.
  • Begin to demonstrate problem-solving skills and creativity.

Responsibilities

  • Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations.
  • Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations.
  • Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets.
  • Serve as a strategic regulatory partner, providing guidance on complex compliance landscapes and facilitating global product approvals.
  • Perform special projects and assignments as directed by Manager.
  • Assemble and maintain CE technical files in accordance with applicable regulatory requirements.
  • Collaborate with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country-specific requirements.
  • Liaise with distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance.
  • We build trusted relationships.

Requirements

  • Bachelor's Degree
  • Ability to take accountability of his/her work, good or bad.
  • Must have "can do" attitude and be a team player.
  • 2+ years of Regulatory Affairs experience in medical devices or other regulated industry. We will also consider a Master's Degree with 1+ years of Regulatory Affairs experience in medical devices or other regulated industry.
  • Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR).
  • Demonstrated international submissions experience (i.e., APAC, LATAM, Australia TGA, Health Canada, and/or EU Technical files a plus).
  • Ability to take accountability of his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers.
  • Maintains a sense of urgency and attention to detail. Must have "can do" attitude and be a team player.
  • Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines.
  • Ability to be flexible and adaptable. Know when to ask questions. Have a positive attitude. Demonstrate a commitment to getting the job done right and on time.

Nice to have

  • Advanced degree or RAC certification preferred.
  • Master's in Regulatory Science preferred.

Skills

  • Be respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again.
  • Ability to challenge the status quo and seek opportunities to set new standards.
  • Must be comfortable dealing with ambiguity, relying on critical thinking to accomplish project goals
  • Be able to see the big picture and how your projects fit into corporate goals and objectives.
  • Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.
  • Highly organized, detail-oriented "mindset" and ability to be flexible and multi-task in a dynamically changing environment.

Compensation

  • At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
  • The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
  • Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs.
  • $85,800 - $104,800

Benefits

  • The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Company info

  • Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires.
  • For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries.
  • Each one is rooted in respect and understanding.
  • We take that approach when we help orthodontists achieve their clinical and practice management objectives.
  • We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.
  • The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
  • Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.
  • Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
  • Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
  • Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.
  • An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
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This listing is sourced directly from Envista's careers page and normalized into a canonical job model.