Working Location: WASHINGTON, REDMOND
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.
Let’s inspire healthier lives, together.
Job Description
The Regulatory Affairs Manager oversees the regulations process for product requiring governmental approval, which may include filing necessary applications and handling of government/regulatory interactions. The manager coordinates inspection of the organization with the appropriate agencies and develops procedures to ensure regulatory compliance.
The candidate works cross-functionally to ensure domestic and international regulatory compliance is maintained across the organization.
Job Duties
* Technical expert for all relevant medical device regulatory bodies (FDA, ISO, etc.) to ensure proper processes, policies, and procedures are in place to obtain and retain necessary regulatory approvals and compliance.
* Monitor external regulatory developments, identify potential risks, and communicate potential issues.
* Liaise with relevant domestic and international regulatory contacts to assess regulatory compliance and issues in accordance with the Company’s strategies and objectives.
* Manage relationships within the relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
* Assure all regulatory submissions are accurate and submitted in a timely manner.
* Ensure all regulatory record-keeping requirements are met.
* Manage and oversee training of Company employees on regulatory matters to ensure compliance with requirements.
* Liaise with Operations department to ensure any regulatory issues are addressed in a timely and efficient manner.
* Liaise with Software Engineering department to ensure software design specifications are compliant with relevant regulations and that any regulatory issues are addressed in a timely and efficient manner.
* Assure all marketing, sales and other written materials (e.g. product labels) and practices are in conformance with regulatory requirements.
* Other Essential Duties as directed.
Job Requirements
REQUIRED QUALIFICATIONS:
* Bachelor’s Degree in Regulatory Affairs or a life sciences field preferred. Equivalent work experience will be considered.
* Minimum of 8 years of experience in a Regulatory role.
* Travel to other Company facilities, vendors, etc. may be required; up to 10% domestic travel.
* Other projects and duties as necessary and assigned.
PREFERRED QUALIFICATIONS:
* RAPS Regulatory Affairs Certification preferred.
* Experience in domestic and international medical device submissions for the US, European, and Asia-Pacific markets, preferred.
* Extensive knowledge of: FDA, CE, and ISO strongly preferred.
* Experience with a medical device quality system preferred.
* Good recordkeeping and attention to detail.
* Organizational skills, detail oriented, trustworthy.
* * The anticipated compensation range for this position is $110,000 to $154,000 USD annually and the compensation offered will depend on the candidate’s qualifications.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks – so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Washington (US-WA) || Redmond ||
Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue
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