What are the responsibilities and job description for the Staff Regulatory Affairs Specialist position at ZEISS Group?
About Us:
How many companies can say they’ve been in business for over 177 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
What’s the role?
The Staff Regulatory Affairs Specialist is responsible for US and international medical device premarket and post-market activities for assigned products. Products include software driven electrical medical devices and standalone software (US Class I, II; EU Class I, Im and IIa). Regulatory responsibilities include, but are not limited to, local and multi-site Product Development Teams, regulatory strategy, applicable standards, guidances and regulations/directives, CE-Marking, Technical Files, Rest of World registrations, marketing collateral, labeling, regulatory intelligence, critical analysis and process/record maintenance. The position works closely with International Regulatory Affairs to ensure that all products currently being sold by Carl Zeiss Meditec have appropriate country approvals/registrations, and that regulatory submissions for new/modified products are completed to facilitate product launches globally.
The Staff Regulatory Affairs Specialist is responsible for US and international medical device premarket and post-market activities for assigned products. Products include software driven electrical medical devices and standalone software (US Class I, II; EU Class I, Im and IIa). Regulatory responsibilities include, but are not limited to, local and multi-site Product Development Teams, regulatory strategy, applicable standards, guidances and regulations/directives, CE-Marking, Technical Files, Rest of World registrations, marketing collateral, labeling, regulatory intelligence, critical analysis and process/record maintenance. The position works closely with International Regulatory Affairs to ensure that all products currently being sold by Carl Zeiss Meditec have appropriate country approvals/registrations, and that regulatory submissions for new/modified products are completed to facilitate product launches globally.
Sound Interesting?
Here’s what you’ll do:
- Serve as regulatory lead for local and multi-site Product Development Teams for software driven electromedical devices, as directed. Responsibilities include: develop regulatory strategies that optimize US, EU and Rest of World product registration; prepare and maintain Regulatory Strategy Plans; determine device classifications; identify applicable standards, guidances, and regulations/directives; participate in risk management; approve Document Change Orders and Engineering Change Orders.
- Serve as regulatory lead for European CE-Marking requirements and strategies for assigned Dublin CA site Product Development Teams. Responsibilities include: obtain and maintain CE-Marking for assigned products; prepare and maintain associated Technical Files and Essential Requirements Checklists; lead Notified Body review and approval of Technical Files; device classification; collaboration with Management Representative, EC Representative, and ZEISS Affiliates.
- Serve as regulatory lead for international registration requirements and strategies for assigned Dublin CA site Product Development Teams. Responsibilities include: Obtain and maintain registration of assigned products in rest of world markets, including Australia, Brazil, Canada, China, Mexico, Japan, Russia, South Korea and Taiwan, in collaboration with ZEISS Affiliates and Distributors.
- Serve as regulatory lead for US registration requirements and strategies, in collaboration with RA US Submission colleagues, for assigned Dublin CA site Product Development Teams. Responsibilities include: device classification and product codes; 510(k) file/no file determinations; 510(k) documentation; as needed, 510(k) preparation.
- Serve as regulatory lead for labeling (manuals, instructions for use, labels, etc.) guidance, review and approval for assigned products taking into account regulations, standards and cleared/approved product claims.
- Perform regulatory searches and notify the organization of changes in US, EU and Rest of World laws, regulations, directives, guidances, standards, etc. that impact ZEISS.• Serve as regulatory lead for local Sustaining Product Teams, as assigned. Responsibilities include: assess the impact of product changes on US, EU and Rest of World registrations.
- Serve as regulatory lead for marketing collateral guidance, review and approval for assigned products taking into account cleared/approved product claims.
- Maintain and work to Company SOPs
- Supports Product Complaint investigations, as required.
- Mentors junior regulatory staff and other team members.
- Performs others duties, as assigned.
Do you qualify?
- Requires a Bachelors degree in an appropriate scientific discipline. Advanced degree preferred.
- A minimum of eight (8) years of medical device regulatory affairs, or industry related experience, with a strong preference for software driven devices. Global regulatory experience preferred.
- Must have excellent communication skills, both written and oral, and must be computer literate.
- Industry recognized certification (RAC) preferred.
SPECIAL DEMANDS:
- This position may require travel domestically and internationally up to 5% of the time
- This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
The annual pay range for this position is $127,800 - $159,700.
The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is eligible for a Performance Bonus.
This position is eligible for a Performance Bonus.
ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.
We have amazing benefits to support you as an employee at ZEISS!
- Medical
- Vision
- Dental
- 401k Matching
- Employee Assistance Programs
- Vacation and sick pay
- The list goes on!
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer
Your ZEISS Recruiting Team:
Clara Cresswell
Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
Salary : $127,800 - $159,700
